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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 K062455
Device Name PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact RICH MCCLEARY
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Correspondent Contact RICH MCCLEARY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/23/2006
Decision Date 11/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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