Cleared Traditional

SALTER LABS INFANT MEDIUM CONCENTRATION MASK

K912633 · Salter Labs · Anesthesiology
Jul 1991
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K912633 is an FDA 510(k) clearance for the SALTER LABS INFANT MEDIUM CONCENTRATION MASK, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on July 19, 1991, 35 days after receiving the submission on June 14, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K912633 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1991
Decision Date July 19, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BYG — Mask, Oxygen
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5580

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