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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Obstetric
510(k) Number K870709
Device Name 7.5 MHZ ENDOVAGINAL PROBE
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 Number884.2960
Classification Product Code
HGL  
Date Received02/20/1987
Decision Date 03/27/1987
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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