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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K841048
Device Name TRANSDUCER 4.OMHZ LA4011
Applicant
Philips Ultrasound, Inc.
2722 S. Fairview
Santa Ana,  CA  92704
Applicant Contact ROBERT F AVRUTIK
Correspondent
Philips Ultrasound, Inc.
2722 S. Fairview
Santa Ana,  CA  92704
Correspondent Contact ROBERT F AVRUTIK
Date Received03/12/1984
Decision Date 01/25/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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