• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K021175
Device Name AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
Applicant
AEROGEN, INC.
1310 Orleans Dr.
Sunnyvale,  CA  94089
Applicant Contact TRACI V. A EDWARDS
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/12/2002
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
-
-