Cleared Traditional

EASY PULSE II OXYGEN CONSERVER

K032018 · Precision Medical, Inc. · Anesthesiology
Aug 2003
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K032018 is an FDA 510(k) clearance for the EASY PULSE II OXYGEN CONSERVER, a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on August 25, 2003, 56 days after receiving the submission on June 30, 2003. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K032018 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2003
Decision Date August 25, 2003
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code NFB — Conserver, Oxygen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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