Cleared Traditional

EDENTEC MODEL 3711 DIGITAL RECORDER

K910870 · Edentec Corp. · Cardiovascular
Aug 1991
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K910870 is an FDA 510(k) clearance for the EDENTEC MODEL 3711 DIGITAL RECORDER, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on August 29, 1991, 181 days after receiving the submission on March 1, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K910870 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1991
Decision Date August 29, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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