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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 K001369
Device Name RESPIEVENTS, VERSION 4.2
Applicant
Non-Invasive Monitoring Systems, Inc.
1840 W. Ave.
Miami Beach,  FL  33139
Applicant Contact MARVIN A SACKNER, M.D.
Correspondent
Non-Invasive Monitoring Systems, Inc.
1840 W. Ave.
Miami Beach,  FL  33139
Correspondent Contact MARVIN A SACKNER, M.D.
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/01/2000
Decision Date 07/26/2000
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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