TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

Oximeter

RADIOMETER BASEL AG

The following data is part of a premarket notification filed by Radiometer Basel Ag with the FDA for Tosca 500 Tcpco2, Spo2 And Pulse Rate Monitoring System.

Pre-market Notification Details

Device IDK063434
510k NumberK063434
Device Name:TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
ClassificationOximeter
Applicant RADIOMETER BASEL AG AUSTRASSE 25 Basel,  CH 4051
ContactJean-pierre Palma
CorrespondentJean-pierre Palma
RADIOMETER BASEL AG AUSTRASSE 25 Basel,  CH 4051
Product CodeDQA  
Subsequent Product CodeDPZ
Subsequent Product CodeLKD
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-13
Decision Date2007-01-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.