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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K965158
Device Name HEART PROTECTOR (VER 1996)
Applicant
N.P.N.T., Inc.
111 Martin Ross Ave.,
Unit #4
Downsview, Ontario,  CA M3J-2M7
Applicant Contact KEN NUSBAUM
Correspondent
N.P.N.T., Inc.
111 Martin Ross Ave.,
Unit #4
Downsview, Ontario,  CA M3J-2M7
Correspondent Contact KEN NUSBAUM
Regulation Number870.2300
Classification Product Code
DRT  
Date Received12/23/1996
Decision Date 12/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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