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 K092847
Device Name 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
Applicant
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Applicant Contact Jean Simon
Correspondent
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Correspondent Contact Jean Simon
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/16/2009
Decision Date 03/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-