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 Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K851940
Device Name STERILE WATER FOR INHALATION USP 2D0799
Applicant
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Applicant Contact DENNIS A OCWIEJA
Correspondent
Travenol Laboratories, S.A.
Deerfield,  IL  60015
Correspondent Contact DENNIS A OCWIEJA
Regulation Number868.5450
Classification Product Code
BTT  
Date Received05/03/1985
Decision Date 06/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-