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 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K042665
Device Name SMART BITEBLOC
Applicant
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST. P.O. BOX 45025
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Applicant Contact SANDY BROWN
Correspondent
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST. P.O. BOX 45025
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Correspondent Contact SANDY BROWN
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
MNK  
Date Received09/29/2004
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-