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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 K063783
Device Name PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
Applicant
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact TAPAN D SHAH
Correspondent
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Correspondent Contact TAPAN D SHAH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/21/2006
Decision Date 04/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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