Cleared Traditional

E-Z SPACER MASK (SMALL)

K964956 · Airpharma, LLC · Anesthesiology

Apr 1997

Decision

133d

Days

Class 1

Risk

About This 510(k) Submission

K964956 is an FDA 510(k) clearance for the E-Z SPACER MASK (SMALL), a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Airpharma, LLC (Ramona, US). The FDA issued a Cleared decision on April 23, 1997, 133 days after receiving the submission on December 11, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.

Submission Details

510(k) Number	K964956 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 1996
Decision Date	April 23, 1997
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF