Cleared Traditional

K913501 - TRACHEOSTOMY MASK
(FDA 510(k) Clearance)

K913501 · B & F Medical Products, Inc. · Anesthesiology device

Jan 1992

Decision

159d

Days

Class 1

Risk

K913501 is an FDA 510(k) clearance for the TRACHEOSTOMY MASK. This device is classified as a Mask, Oxygen (Class I - General Controls, product code BYG).

Submitted by B & F Medical Products, Inc. (Toledo, US). The FDA issued a Cleared decision on January 13, 1992, 159 days after receiving the submission on August 7, 1991.

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

Submission Details

510(k) Number	K913501 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 07, 1991
Decision Date	January 13, 1992
Days to Decision	159 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement