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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 K012020
Device Name RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
Applicant
Non-Invasive Monitoring Systems, Inc.
1840 W. Ave.
Miami Beach,  FL  33139
Applicant Contact ALLAN F BRACK
Correspondent
Non-Invasive Monitoring Systems, Inc.
1840 W. Ave.
Miami Beach,  FL  33139
Correspondent Contact ALLAN F BRACK
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/28/2001
Decision Date 08/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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