Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Ventilator, Continuous, Facility Use
510(k) Number K022674
Device Name BIRD AVEA VENTILATOR
Applicant
Bird Products Corp.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JEFFREY K SHAPIRO
Correspondent
Bird Products Corp.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JEFFREY K SHAPIRO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/12/2002
Decision Date 11/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-