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FDA 510(k)

TCM40 MONITORING SYSTEM

K-Number: K043003 · 2005-03-01

ApplicantRadiometer Medical Aps
Decision Date2005-03-01
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TCM40 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 2005-03-01 under 510(k) number K043003. 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 TCM40 MONITORING SYSTEM?

TCM40 MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-01. The listed applicant is Radiometer Medical Aps. The 510(k) number is K043003.

When did TCM40 MONITORING SYSTEM receive FDA 510(k) clearance?

TCM40 MONITORING SYSTEM received FDA 510(k) clearance on 2005-03-01, under 510(k) number K043003.

Who is the listed applicant for TCM40 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 TCM40 MONITORING SYSTEM?

The FDA product code for TCM40 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 AGK093154TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMRadiometer Medical ApsK043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009Linde Medical Sensors AG

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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