Cleared Traditional

PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150

K103563 · Precision Medical, Inc. · Anesthesiology
Jul 2011
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K103563 is an FDA 510(k) clearance for the PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150, 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 July 1, 2011, 207 days after receiving the submission on December 6, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K103563 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2010
Decision Date July 01, 2011
Days to Decision 207 days
Submission Type Traditional
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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