• 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 cannula, nasal, oxygen
510(k) Number K852628
Device Name NASAL ONE
Applicant
ASHAI CO. LTD.
620 HARRIS ST.
ULTIMO, N.S.W. 2007
AUSTRALIA,  AU
Applicant Contact KALNIN
Correspondent
ASHAI CO. LTD.
620 HARRIS ST.
ULTIMO, N.S.W. 2007
AUSTRALIA,  AU
Correspondent Contact KALNIN
Regulation Number868.5340
Classification Product Code
CAT  
Date Received06/20/1985
Decision Date 09/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-