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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K872817
Device Name 5 MHZ DOPPLER OUTRIGGER
Applicant
PHILIPS ULTRASOUND, INC.
2722 S. FAIRVIEW
SANTA ANA,  CA  92704
Applicant Contact MARTIN A KAUFMAN
Correspondent
PHILIPS ULTRASOUND, INC.
2722 S. FAIRVIEW
SANTA ANA,  CA  92704
Correspondent Contact MARTIN A KAUFMAN
Regulation Number892.1550
Classification Product Code
IYN  
Date Received07/16/1987
Decision Date 02/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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