Clearance Summary
SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE received FDA 510(k) clearance under submission number K080106, sponsored by Leonhard Lang GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-02-01.
- Submission: K080106
- Applicant / Sponsor: Leonhard Lang GmbH
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2008-02-01
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.