Clearance Summary
TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM received FDA 510(k) clearance under submission number K063434, sponsored by Radiometer Basel AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-01-22.
- Submission: K063434
- Applicant / Sponsor: Radiometer Basel AG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2007-01-22
Classification & Regulation
This clearance is catalogued under FDA product code DQA and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.