Clearance Summary
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 received FDA 510(k) clearance under submission number K101660, sponsored by Kepler Medtec. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-08-11.
- Submission: K101660
- Applicant / Sponsor: Kepler Medtec
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2010-08-11
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.