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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antimicrobial Blood Pressure Cuff
510(k) Number K071885
Device Name ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact PETER SCHIPELLITI
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact PETER SCHIPELLITI
Regulation Number870.1120
Classification Product Code
OED  
Date Received07/09/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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