Clearance Summary
HEARTONE EVENT RECORDER AND TRANSMITTER received FDA 510(k) clearance under submission number K023418, sponsored by Aerotel Medical Systems (1998) , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-11-06.
- Submission: K023418
- Applicant / Sponsor: Aerotel Medical Systems (1998) , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 2002-11-06
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.