AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K021175
Device Name AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
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 04/12/2002
Decision Date 05/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

Yes

Recalls CDRH Recalls