• 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, Oxygen, Gaseous-Phase
510(k) Number K123195
Device Name CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
Applicant
GE HEALTHCARE FINLAND OY
KUORTANEENKATU 2
HELSINKI,  FI FIN-00510
Applicant Contact RAUNO RUOHO
Correspondent
GE HEALTHCARE FINLAND OY
KUORTANEENKATU 2
HELSINKI,  FI FIN-00510
Correspondent Contact RAUNO RUOHO
Regulation Number868.1720
Classification Product Code
CCL  
Date Received10/11/2012
Decision Date 02/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-