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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 K910870
Device Name EDENTEC MODEL 3711 DIGITAL RECORDER
Applicant
Edentec Corp.
10252 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact Gary Syring
Correspondent
Edentec Corp.
10252 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact Gary Syring
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/01/1991
Decision Date 08/29/1991
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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