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FDA 510(k)

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

K-Number: K032291 · 2004-08-24

ApplicantLinde Medical Sensors AG
Decision Date2004-08-24
Product CodeDOA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM 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 2004-08-24 under 510(k) number K032291. The device is classified under product code DOA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM?

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-24. The listed applicant is Linde Medical Sensors AG. The 510(k) number is K032291.

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

TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM received FDA 510(k) clearance on 2004-08-24, under 510(k) number K032291.

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

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 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM?

The FDA product code for TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM is DOA.

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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.

K043357TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009K003943MICROGAS 7650 TRANSCUTANEOUS MONITORK991644MICROGAS 7650 TRANSCUTANEOUS MONITOR

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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