Cleared Traditional

MANIFOLD/NEBULIZER BREATHING PRODUCTS

K791469 · Hospitak, Inc. · Anesthesiology

Aug 1979

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K791469 is an FDA 510(k) clearance for the MANIFOLD/NEBULIZER BREATHING PRODUCTS, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1979, 22 days after receiving the submission on August 6, 1979. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number	K791469 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 1979
Decision Date	August 28, 1979
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—