Cleared Traditional

SIGMA ALPHA VAPORIZER

K060331 · Penlon Limited · Anesthesiology
May 2006
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K060331 is an FDA 510(k) clearance for the SIGMA ALPHA VAPORIZER, a Vaporizer, Anesthesia, Non-heated (Class II — Special Controls, product code CAD), submitted by Penlon Limited (West Sussex, GB). The FDA issued a Cleared decision on May 10, 2006, 90 days after receiving the submission on February 9, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5880.

Submission Details

510(k) Number K060331 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2006
Decision Date May 10, 2006
Days to Decision 90 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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