Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009

FDA 510(k) K043357 · Linde Medical Sensors AG

Substantially Equivalent

510(k) numberK043357

Submission

Device name
Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009
Applicant
Linde Medical Sensors AG
Basel, CH
Received
December 6, 2004
Decision date
March 4, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LKD – Monitor, Carbon-Dioxide, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2480
Specialty
Anesthesiology

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K093154TCM Tosca Monitoring System, TCM Combim Monitoring SystemLKD · Traditional Radiometer Medical Aps02/05/2010SE
K043003TCM40 Monitoring SystemLKD · Abbreviated Radiometer Medical Aps03/01/2005SE
K041548Sentec Digital Monitor Model #SdmLKD · Traditional Sentec, Inc.08/09/2004SE
K990960Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040)LKD · Traditional Perimed, Inc.09/23/1999SE
K980756Corometrics Transcutaneous TCPO2/CO2 ModuleLKD · Traditional Ge Medical Systems Information Technologies11/05/1998SE

More from Ge Medical Systems Information Technologies

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K032291Tosca PCO2, SPO2 and Pulse Rate Monitoring SystemDOA · Traditional 08/24/2004SE
K003943Microgas 7650 Transcutaneous MonitorKLK · Special 05/04/2001SE
K991644Microgas 7650 Transcutaneous MonitorKLK · Special 05/21/1999SE

Questions and answers

When was Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009 cleared by the FDA?

Tosca 500 PCO2, SPO2 and Pulse Rate Monitoring System, Model 5202009 (K043357) received a 510(k) decision of Substantially Equivalent on March 4, 2005, 88 days after the submission was received.

What is the product code of K043357?

The FDA product code is LKD – Monitor, Carbon-Dioxide, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 868.2480.