• 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 K970460
Device Name NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
Applicant
PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Applicant Contact ANN-MARIE BUTLER
Correspondent
PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Correspondent Contact ANN-MARIE BUTLER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/06/1997
Decision Date 04/30/1998
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
-
-