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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K083413
Device Name COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact TERESA SCHMIDT
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Correspondent Contact TERESA SCHMIDT
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received11/18/2008
Decision Date 12/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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