Clearance Summary
9267 SPO2 ATHENA MODULE received FDA 510(k) clearance under submission number K940933, sponsored by S & W Medico Teknik. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-11-29.
- Submission: K940933
- Applicant / Sponsor: S & W Medico Teknik
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 1995-11-29
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.