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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 K062605
Device Name PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact RICH MCCLEARY
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact RICH MCCLEARY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/05/2006
Decision Date 11/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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