Clearance Summary
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR received FDA 510(k) clearance under submission number K973863, sponsored by Hi-Tronics Designs, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-01-02.
- Submission: K973863
- Applicant / Sponsor: Hi-Tronics Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 1998-01-02
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.