Cleared Traditional

PRECISION LIQUID OXYGEN SYSTEM

K041122 · Precision Medical, Inc. · Anesthesiology
Oct 2004
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K041122 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 October 4, 2004, 158 days after receiving the submission on April 29, 2004. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number K041122 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2004
Decision Date October 04, 2004
Days to Decision 158 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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