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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 Echo, Ultrasonic
510(k) Number K854654
Device Name SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007
Applicant
Philips Medical Systems, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Applicant Contact MARTIN A KAUFMAN
Correspondent
Philips Medical Systems, Inc.
2722 S. Fairview St.
Santa Ana,  CA  92704
Correspondent Contact MARTIN A KAUFMAN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/19/1985
Decision Date 08/19/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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