Cleared Traditional

K940220 - REBREATHER BAGS
(FDA 510(k) Clearance)

K940220 · Zefon Medical Products · Anesthesiology
May 1994
Decision
126d
Days
Class 1
Risk

K940220 is an FDA 510(k) clearance for the REBREATHER BAGS, a Bag, Reservoir (Class I — General Controls, product code BTC), submitted by Zefon Medical Products (Ocala, US). The FDA issued a Cleared decision on May 27, 1994, 126 days after receiving the submission on January 21, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5320.

Submission Details

510(k) Number K940220 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1994
Decision Date May 27, 1994
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTC — Bag, Reservoir
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5320