Cleared Traditional

GAV - GENERAL ANAESTHETIC VAPORIZER

K051666 · General Anaesthetic Services Limited · Anesthesiology
Aug 2005
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K051666 is an FDA 510(k) clearance for the GAV - GENERAL ANAESTHETIC VAPORIZER, a Vaporizer, Anesthesia, Non-heated (Class II — Special Controls, product code CAD), submitted by General Anaesthetic Services Limited (Keighley, West Yorkshire, GB). The FDA issued a Cleared decision on August 23, 2005, 62 days after receiving the submission on June 22, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K051666 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2005
Decision Date August 23, 2005
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAD — Vaporizer, Anesthesia, Non-heated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5880

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