Cleared Special

CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S

K103635 · Aerogen, Ltd. · Anesthesiology

May 2011

Decision

151d

Days

Class 2

Risk

About This 510(k) Submission

K103635 is an FDA 510(k) clearance for the CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Aerogen, Ltd. (Galway, IE). The FDA issued a Cleared decision on May 13, 2011, 151 days after receiving the submission on December 13, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number	K103635 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2010
Decision Date	May 13, 2011
Days to Decision	151 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Statement