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 Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K043357
Device Name TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
Applicant
Linde Medical Sensors AG
Austrasse 25
Basel,  CH 4051
Applicant Contact JEAN-PIERRE PALMA
Correspondent
Linde Medical Sensors AG
Austrasse 25
Basel,  CH 4051
Correspondent Contact JEAN-PIERRE PALMA
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Code
DPZ  
Date Received12/06/2004
Decision Date 03/04/2005
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
-
-