AERONEB PORTABLE NEBULIZER


definition

Device Classification Name

nebulizer (direct patient interface)

510(k) Number K003022
Device Name AERONEB PORTABLE NEBULIZER
Original Applicant
AEROGEN, INC.
1310 orleans dr.
sunnyvale, 
CA 
94089

Original Contact traci v.a. edwards
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 09/28/2000
Decision Date 10/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

Yes