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 Oximeter
510(k) Number K063434
Device Name TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
Applicant
Radiometer Basel AG
Austrasse 25
Basel,  CH 4051
Applicant Contact JEAN-PIERRE PALMA
Correspondent
Radiometer Basel AG
Austrasse 25
Basel,  CH 4051
Correspondent Contact JEAN-PIERRE PALMA
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DPZ   LKD  
Date Received11/13/2006
Decision Date 01/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-