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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 K881028
Device Name 7.5 MHZ ENDORECTAL 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 Number892.1560
Classification Product Code
IYO  
Date Received03/10/1988
Decision Date 04/27/1988
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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