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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 K033646
Device Name TRIFIT 700
Applicant
Healthfirst Corp.
13170-B Central Ave. SE
Suite 115
Albuquerque,  NM  87123
Applicant Contact JAY SKOLNIK
Correspondent
Healthfirst Corp.
13170-B Central Ave. SE
Suite 115
Albuquerque,  NM  87123
Correspondent Contact JAY SKOLNIK
Regulation Number870.2300
Classification Product Code
DRT  
Date Received11/20/2003
Decision Date 03/01/2005
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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