TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM— 510(k) K063434

Substantially Equivalent

Radiometer Basel AG

FDA 510(k) clearance K063434 for TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, Substantially Equivalent on 2007-01-22. Applicant: Radiometer Basel AG.

Clearance details

Applicant: Radiometer Basel AG
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2006-11-13
Decision date: 2007-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel, CH

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.