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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 K902691
Device Name DOPPLER OPTION FOR PLATINUM
Applicant
Philips Medical Systems, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Applicant Contact GLADYS D MAY
Correspondent
Philips Medical Systems, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Correspondent Contact GLADYS D MAY
Regulation Number892.1550
Classification Product Code
IYN  
Date Received06/19/1990
Decision Date 01/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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