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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 K861358
Device Name PS SYSTEM WITH SD-200 DOPPLER
Applicant
Johnson & Johnson Professionals, Inc.
69 Spring St.
Ramsey,  NJ  07446
Applicant Contact RAYMOND F CHASE
Correspondent
Johnson & Johnson Professionals, Inc.
69 Spring St.
Ramsey,  NJ  07446
Correspondent Contact RAYMOND F CHASE
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/10/1986
Decision Date 07/30/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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