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  0 of 0 people found the following review helpful:
 
My CMS50H April 5, 2013
Reviewer: PETER LOGUE from FOREST HILLS QUEENS, NY United States  
I love it

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CMS50H Fingertip Pulse Oximeter field Review October 5, 2012
Reviewer: Confused from Bloomington, IL United States  
Excellent product but someone needs to provide a good users manual for it.

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SUCKS! May 15, 2012
Reviewer: John T. from San Diego, CA United States  
This product broke the first night I used it. The screen froze in vertical display mode and I couldn't access the menu for 24 hours until it reset itself??? It worked okay for another 8 hours and then did this again. I am returning this product A.S.A.P. SAVE YOUR MONEY.

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CMS50H May 8, 2012
Reviewer: RICHARD LARSON from Midwest City, OK United States  
More of a question:  The only thing I found in the Manual on the "Repetition Rate of Data Saved/Displayed"  Was less than 5 sec???
It would be nice if the operator had the ability to change the Sample Rate. (Even knowing it would shorten the overall Time of Data saved from 24 hours to say 6 hours.)  Just a thought.
P.S. I have Sleep Apnea and would love to accurately view each occurrence.

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3 May 2, 2012
Reviewer: Ronald Smith from 3  
3

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Fantastic December 26, 2011
Reviewer: Anonymous Person from Owings Mills, MD United States  
I am impressed with both the rapid service and the quality of the product.
No problems with the use of pulse ox or enclosed software. Everything working well. I highly recommend!
Thankyou.

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glad I purchased it November 23, 2011
Reviewer: dave from tucson, AZ United States  
if your finger isn't in it, it powers down in ~3 seconds... I wish the time was either more reasonable (20-30 seconds) or configurable.

the included software is Winblows only. I've had limited success with wine under Mac OSX (reports work once the data is copied in from Winblows machine)

the device itself is very nice; light weight, comfortable  over night, and quick to produce an answer (if you're just looking to read your pulse) and easy to read.

the device only has a single button, but it's surprisingly easy to operate.

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CMS50H oximeter June 13, 2011
Reviewer: Douglas Finnie from Cherry Valley, CA United States  
The oximeter is excellent. However the operator Manual is vague and the instructions are difficult to follow. I have downloaded the software but I am unable to connect the device to upload recorded data to my computer. Help would be appreciated.
Thanks,
Doug Finnie

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  2 of 3 people found the following review helpful:
 
needs Rx and is not FDA approved December 28, 2010
Reviewer: William from Charlotte, NC  
This device requires a prescription as stated by the FDA governing Class II Medical Devices.  The CMS50-H is NOT FDA-510K approved for sale in the USA.

[CPAP-Supply.com Note: Although this isn't a product review, we feel it's important to publish so that we can respond and educate our customers.

First, we publish the FDA K numbers for all the oximeters that have them. The 50H is pending FDA approval and as such does not have an FDA K number. As a result of this, the CMS50H is not considered a medical device, and a prescription, therefore, is not required.

Second, the FDA suggests pulse oximeters can be sold over-the-counter without a prescription given a few conditions, mostly regarding instructions that are included with the oximeter. Here's a quote from the FDA: "The decision to allow a prescription device to be used over-the-counter (OTC) hinges on whether adequate instructions can be written for the layperson and whether the risks exceed the benefits. For pulse oximeters, there are existing non medical uses – mountain climbing and spelunking (high and low altitude) acclimation."

The instructions included with our pulse oximeters meet the FDA's guidelines for being appropriate and thorough for OTC sales, and we expect most, if not all, of our customers to use pulse oximeters on their own for their own personal use - spot checking during exercise, recording for an hour or two while sleeping, etc.

So, in summary, a device that isn't registered with the FDA is, by definition, a non-prescription device. The pulse oximeters that are registered by the FDA can be sold over-the-counter without a prescription if certain conditions outlined by the FDA are met.]

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