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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 NameGLUCOWATCH 2 BIOGRAPHER
Classification Nameglucose oxidase, glucose
Generic Nameinstrument, glucose, noninvasive technology\
Regulation Number862.1345
ApplicantCYGNUS, INC.
PMA NumberP990026
Supplement NumberS011
Date Received12/11/2001
Decision Date03/21/2002
Product Code
CGA[ Registered Establishments with CGA ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the electrical hardware and software of the original glucowatch automatic glucose biographer. The device, as modified, will be marketed under the trade name glucowatch2 biographer and is indicated for: the glucowatch2 biographer is a glucose monitoring device intended for detecting trends and tracking patterns in glucose levels in adults (age 18 and older) with diabetes. This device is intended for use by patients at home and in healthcare facilities. The device is for prescription use only. The glucowatch 2 biographer is intended for use as an adjunctive device to supplement, not replace, information obtained from standard home glucose monitoring devices. The glucowatch2 biographer is indicated for use in the detection and assessment of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of biographer results should be based on the trends and patterns seen with several sequential readings over time.
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