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


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K103635
Device Name CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
Applicant
AEROGEN LTD
galway business park, dangan
galway, 

IE

galway

Applicant Contact martha folan
Correspondent
AEROGEN LTD
galway business park, dangan
galway, 

IE

galway

Correspodent Contact martha folan
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 12/13/2010
Decision Date 05/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No