Cleared Traditional

PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)

K990678 · Salter Labs · Anesthesiology
May 1999
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K990678 is an FDA 510(k) clearance for the PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC), a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on May 7, 1999, 66 days after receiving the submission on March 2, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K990678 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1999
Decision Date May 07, 1999
Days to Decision 66 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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