Cleared Traditional

N20 TEST

K853360 · Erich Jaeger, Inc. · Anesthesiology
Sep 1985
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K853360 is an FDA 510(k) clearance for the N20 TEST, a Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.) (Class II — Special Controls, product code CBR), submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on September 3, 1985, 22 days after receiving the submission on August 12, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1700.

Submission Details

510(k) Number K853360 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1985
Decision Date September 03, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBR — Analyzer, Gas, Nitrous-oxide, Gaseous Phase (anesthetic Conc.)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1700