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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K861710
Device Name MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
Applicant
Johnson & Johnson Professionals, Inc.
69 Spring St.
Ramsey,  NJ  07446
Applicant Contact RAYMOND CHASE
Correspondent
Johnson & Johnson Professionals, Inc.
69 Spring St.
Ramsey,  NJ  07446
Correspondent Contact RAYMOND CHASE
Regulation Number870.2330
Classification Product Code
DXK  
Date Received05/05/1986
Decision Date 07/09/1986
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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