Cleared Traditional

K913164 - NON REBREATHING MASK
(FDA 510(k) Clearance)

K913164 · Specialty Packaging Producs, Inc. · Anesthesiology device

Jan 1992

Decision

182d

Days

Class 1

Risk

K913164 is an FDA 510(k) clearance for the NON REBREATHING MASK. This device is classified as a Mask, Oxygen, Non-rebreathing (Class I - General Controls, product code KGB).

Submitted by Specialty Packaging Producs, Inc. (El Paso, US). The FDA issued a Cleared decision on January 15, 1992, 182 days after receiving the submission on July 17, 1991.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5570.

Submission Details

510(k) Number	K913164 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 17, 1991
Decision Date	January 15, 1992
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF