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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K881185
Device Name ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
Applicant
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Applicant Contact WILLIAM J GERBER
Correspondent
Philips Medical Systems (Cleveland), Inc.
5500 Avion Park Dr.
Highland Heights,  OH  44143
Correspondent Contact WILLIAM J GERBER
Regulation Number884.2225
Classification Product Code
HEM  
Date Received03/21/1988
Decision Date 06/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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