Clearance Summary
CARDTEL, MODEL NT-100 received FDA 510(k) clearance under submission number K000609, sponsored by Cardiac Telecommunications. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-05-23.
- Submission: K000609
- Applicant / Sponsor: Cardiac Telecommunications
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2000-05-23
Classification & Regulation
This clearance is catalogued under FDA product code MWJ and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.