Cleared Traditional

EZ SPRAY

K972397 · Intertex Research, Inc. · Anesthesiology

Sep 1997

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K972397 is an FDA 510(k) clearance for the EZ SPRAY, a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Intertex Research, Inc. (Houston, US). The FDA issued a Cleared decision on September 23, 1997, 89 days after receiving the submission on June 26, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.

Submission Details

510(k) Number	K972397 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 1997
Decision Date	September 23, 1997
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF