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 K083693
Device Name PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
Applicant
Covidien, Formerly Nellcor Puritan Bennett, Inc.
2101 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact KIM BLOOM
Correspondent
Covidien, Formerly Nellcor Puritan Bennett, Inc.
2101 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact KIM BLOOM
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/12/2008
Decision Date 04/02/2009
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
-
-