Clearance Summary
MODEL 621/624 BIOMAGNETOMETER received FDA 510(k) clearance under submission number K151135, sponsored by Tristan Technologies, 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 2016-03-15.
- Submission: K151135
- Applicant / Sponsor: Tristan Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2016-03-15
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.