Cleared Traditional

AEROCHAMBER

K872037 · Monaghan Medical Corp. · Anesthesiology
Jul 1987
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K872037 is an FDA 510(k) clearance for the AEROCHAMBER, a Mouthpiece, Breathing (Class I — General Controls, product code BYP), submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on July 24, 1987, 58 days after receiving the submission on May 27, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number K872037 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 1987
Decision Date July 24, 1987
Days to Decision 58 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYP — Mouthpiece, Breathing
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5620

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