Cleared Traditional

K913275 - VENTURI OXYGEN MASK (FDA 510(k) Clearance)

K913275 · Specialty Packaging Producs, Inc. · Anesthesiology device

Oct 1991

Decision

79d

Days

Class 1

Risk

K913275 is an FDA 510(k) clearance for the VENTURI OXYGEN MASK. This device is classified as a Mask, Oxygen (Class I - General Controls, product code BYG).

Submitted by Specialty Packaging Producs, Inc. (El Paso, US). The FDA issued a Cleared decision on October 10, 1991, 79 days after receiving the submission on July 23, 1991.

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

Submission Details

510(k) Number	K913275 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 23, 1991
Decision Date	October 10, 1991
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF