Clearance Summary
ER800 SERIES ECG EVENT RECORDER received FDA 510(k) clearance under submission number K030856, sponsored by Braemar Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-03-28.
- Submission: K030856
- Applicant / Sponsor: Braemar Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2003-03-28
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.