Cleared Traditional

EDENTEC DIGITAL CHARTER MODEL 3710

K910871 · Edentec Corp. · Cardiovascular
Aug 1991
Decision
181d
Days
Class 1
Risk

About This 510(k) Submission

K910871 is an FDA 510(k) clearance for the EDENTEC DIGITAL CHARTER MODEL 3710, a Recorder, Paper Chart (Class I — General Controls, product code DSF), 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 870.2810.

Submission Details

510(k) Number K910871 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 DSF — Recorder, Paper Chart
Device Class Class I — General Controls
CFR Regulation 21 CFR 870.2810