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FDA 510(k)

TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM

K-Number: K093154 · 2010-02-05

ApplicantRadiometer Medical Aps
Decision Date2010-02-05
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medical Aps. It received FDA 510(k) clearance on 2010-02-05 under 510(k) number K093154. The device is classified under product code LKD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM?

TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-05. The listed applicant is Radiometer Medical Aps. The 510(k) number is K093154.

When did TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM receive FDA 510(k) clearance?

TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM received FDA 510(k) clearance on 2010-02-05, under 510(k) number K093154.

Who is the listed applicant for TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM?

The FDA 510(k) record lists Radiometer Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM?

The FDA product code for TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM is LKD.

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Related Devices (Code: LKD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AGK131253PERIFLUX 6000Perimed ABK110474PHILIPS INTELLIVUE TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac ANK101690SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLESentec AGK043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009Linde Medical Sensors AGK043003TCM40 MONITORING SYSTEMRadiometer Medical Aps

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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