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 K123043
Device Name IRMA C02 MODEL 200101; IRMA AX 200601
Applicant
Phasein AB
404 Williamson St.
Suite 402
Madison,  WI  53703
Applicant Contact DAVID WEISSBURG
Correspondent
Phasein AB
404 Williamson St.
Suite 402
Madison,  WI  53703
Correspondent Contact DAVID WEISSBURG
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CBQ   CBR   CBS   NHO   NHP  
NHQ  
Date Received09/28/2012
Decision Date 10/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-