Cleared Traditional

EDENTEC MODEL 3710 I DIGITAL PRINTER

K921819 · Edentec Corp. · Anesthesiology
Oct 1993
Decision
555d
Days
Class 2
Risk

About This 510(k) Submission

K921819 is an FDA 510(k) clearance for the EDENTEC MODEL 3710 I DIGITAL PRINTER, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on October 22, 1993, 555 days after receiving the submission on April 15, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K921819 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1992
Decision Date October 22, 1993
Days to Decision 555 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZQ — Monitor, Breathing Frequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375

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