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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
510(k) Number K864980
Device Name 3MHZ ANNULAR ARRAY
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 Number870.2880
Classification Product Code
JOP  
Date Received12/22/1986
Decision Date 05/11/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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