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 K923946
Device Name CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER
Applicant
HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA,  CA  92589 -9020
Applicant Contact WILLIAM H MURPHY
Correspondent
HUDSON RESPIRATORY CARE, INC.
27711 DIAZ RD.
P.O. BOX 9020
TEMECULA,  CA  92589 -9020
Correspondent Contact WILLIAM H MURPHY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/05/1992
Decision Date 10/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-