Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

K-Number: K063434 · 2007-01-22

ApplicantRadiometer Basel AG
Decision Date2007-01-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Basel AG. It received FDA 510(k) clearance on 2007-01-22 under 510(k) number K063434. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM?

TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-22. The listed applicant is Radiometer Basel AG. The 510(k) number is K063434.

When did TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM receive FDA 510(k) clearance?

TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM received FDA 510(k) clearance on 2007-01-22, under 510(k) number K063434.

Who is the listed applicant for TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM?

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

What is the FDA product code for TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM?

The FDA product code for TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM is DQA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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.

↑