Cleared Traditional

K844008 - PENLON AM1000 ANAESTHESIA MACHINE
(FDA 510(k) Clearance)

K844008 · Penlon, Inc. · Anesthesiology

Mar 1985

Decision

151d

Days

Class 2

Risk

K844008 is an FDA 510(k) clearance for the PENLON AM1000 ANAESTHESIA MACHINE, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Penlon, Inc. (Abingdon Ox, GB). The FDA issued a Cleared decision on March 12, 1985, 151 days after receiving the submission on October 12, 1984. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number	K844008 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 1984
Decision Date	March 12, 1985
Days to Decision	151 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—