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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 K971397
Device Name VIEWCATH 3-D CATHETER PULLBACK
Applicant
Quinton, Inc.
1043 Kiel Ct.
Sunnyvale,  CA  94089
Applicant Contact ROY A SMITH
Correspondent
Quinton, Inc.
1043 Kiel Ct.
Sunnyvale,  CA  94089
Correspondent Contact ROY A SMITH
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/15/1997
Decision Date 08/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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