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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K021778
Device Name PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact DAVE OSBORN
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact DAVE OSBORN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
GWQ   MHX  
Date Received05/30/2002
Decision Date 07/17/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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