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 heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K153234
Device Name AirLife Adult Heated Wire Circuit
Applicant
CAREFUSION INC
75 N FAIRWAY DRIVE
VERNON HILLS,  IL  60060 1
Applicant Contact ERIKA FERNANDEZ
Correspondent
CAREFUSION INC
75 N FAIRWAY DRIVE
VERNON HILLS,  IL  60060 1
Correspondent Contact ERIKA FERNANDEZ
Regulation Number868.5270
Classification Product Code
BZE  
Date Received11/09/2015
Decision Date 07/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-