Cleared Traditional

PRECISION LIQUID OXYGEN SYSTEM

K103324 · Precision Medical, Inc. · Anesthesiology
Apr 2011
Decision
160d
Days
Class 2
Risk

About This 510(k) Submission

K103324 is an FDA 510(k) clearance for the PRECISION LIQUID OXYGEN SYSTEM, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on April 21, 2011, 160 days after receiving the submission on November 12, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K103324 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2010
Decision Date April 21, 2011
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYJ — Unit, Liquid-oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5655

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