Cleared Traditional

AV-S ANAESTHESIA VENTILATOR

K051222 · Penlon Limited · Anesthesiology
Sep 2005
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K051222 is an FDA 510(k) clearance for the AV-S ANAESTHESIA VENTILATOR, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Penlon Limited (Oxon, GB). The FDA issued a Cleared decision on September 23, 2005, 134 days after receiving the submission on May 12, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K051222 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2005
Decision Date September 23, 2005
Days to Decision 134 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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