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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, breathing frequency
510(k) Number K896934
Device Name KNIGHTWATCH SYSTEM
Applicant
CREATECH CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Applicant Contact STEPHEN LAWRENCE
Correspondent
CREATECH CORP.
COLUMBIA SQUARE
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Correspondent Contact STEPHEN LAWRENCE
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received12/13/1989
Decision Date 06/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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