Clearance Summary
DIGITAL ECG HOLTER RECORDER, MODEL DR512 received FDA 510(k) clearance under submission number K982975, sponsored by Datrix. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-11-10.
- Submission: K982975
- Applicant / Sponsor: Datrix
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1998-11-10
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.