Clearance Summary
MEMORYTRACE ATM MODEL 4222 received FDA 510(k) clearance under submission number K941898, 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 1995-06-26.
- Submission: K941898
- Applicant / Sponsor: Hi-Tronics Designs, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 1995-06-26
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.