Cleared Traditional

DISPOSABLE, CPAP OXYGEN MASK

K945482 · Fvtnks · Anesthesiology
Sep 1995
Decision
315d
Days
Class 1
Risk

About This 510(k) Submission

K945482 is an FDA 510(k) clearance for the DISPOSABLE, CPAP OXYGEN MASK, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Fvtnks (Sturgis, US). The FDA issued a Cleared decision on September 19, 1995, 315 days after receiving the submission on November 8, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K945482 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1994
Decision Date September 19, 1995
Days to Decision 315 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