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FDA 510(k)

TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009

K-Number: K043357 · 2005-03-04

ApplicantLinde Medical Sensors AG
Decision Date2005-03-04
Product CodeLKD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 is the device name listed in this FDA 510(k) record. The listed applicant is Linde Medical Sensors AG. It received FDA 510(k) clearance on 2005-03-04 under 510(k) number K043357. 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 TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009?

TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 is a medical device that received FDA 510(k) clearance on 2005-03-04. The listed applicant is Linde Medical Sensors AG. The 510(k) number is K043357.

When did TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 receive FDA 510(k) clearance?

TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 received FDA 510(k) clearance on 2005-03-04, under 510(k) number K043357.

Who is the listed applicant for TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009?

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

What is the FDA product code for TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009?

The FDA product code for TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 is LKD.

Related Clinical Trials

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.

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Other records listing Linde Medical Sensors AG as applicant

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.

K032291TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEMK003943MICROGAS 7650 TRANSCUTANEOUS MONITORK991644MICROGAS 7650 TRANSCUTANEOUS MONITOR

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 ApsK043003TCM40 MONITORING SYSTEMRadiometer Medical Aps

Official Source

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

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