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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 K043604
Device Name LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
Applicant
Vivometrics, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Vivometrics, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/29/2004
Decision Date 04/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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