Cleared Traditional

NITROUS OXIDE RECYCLER

K834535 · G & L Unltd. · Anesthesiology
Jun 1984
Decision
168d
Days
Class 1
Risk

About This 510(k) Submission

K834535 is an FDA 510(k) clearance for the NITROUS OXIDE RECYCLER, a Absorber, Carbon-dioxide (Class I — General Controls, product code BSF), submitted by G & L Unltd. (Walker, US). The FDA issued a Cleared decision on June 7, 1984, 168 days after receiving the submission on December 22, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5310.

Submission Details

510(k) Number K834535 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1983
Decision Date June 07, 1984
Days to Decision 168 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BSF — Absorber, Carbon-dioxide
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5310