Clearance Summary
TESLA GUARD, MODEL EFT G04 received FDA 510(k) clearance under submission number K071802, sponsored by Mammendorfer Institut Fur Physik Und Medizin 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 2007-11-09.
- Submission: K071802
- Applicant / Sponsor: Mammendorfer Institut Fur Physik Und Medizin GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2007-11-09
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.