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 K112368
Device Name CAPNOSTREAM20P WITH AI/ODI
Applicant
ORIDION MEDICAL 1987 LTD.
7 HAMARPE STREET, HAR
HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Applicant Contact RACHEL WEISSBROD
Correspondent
ORIDION MEDICAL 1987 LTD.
7 HAMARPE STREET, HAR
HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Correspondent Contact RACHEL WEISSBROD
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
DQA   MNR  
Date Received08/17/2011
Decision Date 07/19/2012
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
-
-