Cleared Traditional

K823532 - STOCK #64091-PEDIATRIC OXYGEN MASK
(FDA 510(k) Clearance)

K823532 · B & F Medical Products, Inc. · Anesthesiology device

Jan 1983

Decision

37d

Days

Class 1

Risk

K823532 is an FDA 510(k) clearance for the STOCK #64091-PEDIATRIC OXYGEN MASK. This device is classified as a Mask, Oxygen (Class I - General Controls, product code BYG).

Submitted by B & F Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983, 37 days after receiving the submission on November 29, 1982.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number	K823532 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 29, 1982
Decision Date	January 05, 1983
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—