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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K914105
Device Name CATHWRITER(TM)
Applicant
Softheart, Inc.
38 Brewer Pkwy.
South Burlington,  VT  05403
Applicant Contact HENRY A GELLER
Correspondent
Softheart, Inc.
38 Brewer Pkwy.
South Burlington,  VT  05403
Correspondent Contact HENRY A GELLER
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/13/1991
Decision Date 02/26/1992
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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