Cleared Traditional

PENLON JUMBO CARBON DIOXIDE ABSORBER

K801255 · Penlon, Inc. · Anesthesiology
Jun 1980
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K801255 is an FDA 510(k) clearance for the PENLON JUMBO CARBON DIOXIDE ABSORBER, a Absorber, Carbon-dioxide (Class I — General Controls, product code BSF), submitted by Penlon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 4, 1980, 7 days after receiving the submission on May 28, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5310.

Submission Details

510(k) Number K801255 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1980
Decision Date June 04, 1980
Days to Decision 7 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