Clearance Summary
TESLAOXYSAT, MODEL EFOXYSATE received FDA 510(k) clearance under submission number K050018, sponsored by Mammendorfer Institute For Physics & Medicine GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-07-01.
- Submission: K050018
- Applicant / Sponsor: Mammendorfer Institute For Physics & Medicine GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2005-07-01
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.