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 K070899
Device Name PURITAN BENNETT LEGENDAIR XL2
Applicant
Nellcor Puritan Bennett
4280 Hacienda Dr.
Pleasanton,  CA  94588
Applicant Contact JAMES BONDS
Correspondent
Nellcor Puritan Bennett
4280 Hacienda Dr.
Pleasanton,  CA  94588
Correspondent Contact JAMES BONDS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/02/2007
Decision Date 12/13/2007
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
-
-