Cleared Abbreviated

PRECISION OXYGEN CONCENTRATOR

K072348 · Precision Medical, Inc. · Anesthesiology
Oct 2008
Decision
433d
Days
Class 2
Risk

About This 510(k) Submission

K072348 is an FDA 510(k) clearance for the PRECISION OXYGEN CONCENTRATOR, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on October 27, 2008, 433 days after receiving the submission on August 21, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K072348 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2007
Decision Date October 27, 2008
Days to Decision 433 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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