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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K152363
Device Name Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  03104
Applicant Contact MARY KRUITWAGEN
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  03104
Correspondent Contact MARY KRUITWAGEN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received08/20/2015
Decision Date 10/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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