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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSLEEP SENTRY
Classification Namemonitor, skin resistance/skin temperature, for insulin reactions
Generic Nametemperature & skin resistance measuring device for
ApplicantDIABETES SENTRY PRODUCTS INC.
PMA NumberP810044
Supplement NumberS004
Date Received04/30/2002
Decision Date06/12/2003
Product Code
LMY[ Registered Establishments with LMY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the physical design and layout of the device, device labeling, and manufacturing facilities and processes. The manufacturing sites are located at diabetes sentry products, inc. (dsp), bellingham washington and datrend systems, inc. , richmond, bc canada.
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