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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, Diagnostic
510(k) Number K844772
Device Name 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU
Applicant
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Applicant Contact ROBERT T JOSSICK
Correspondent
Philips Medical Systems, Inc.
Veenpluis 4-6
P.O. Box 10000
5680 Da Best,  NL
Correspondent Contact ROBERT T JOSSICK
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/05/1984
Decision Date 04/17/1986
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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