Clearance Summary
BT-400 received FDA 510(k) clearance under submission number K142332, sponsored by Bio-Med USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2015-03-20.
- Submission: K142332
- Applicant / Sponsor: Bio-Med USA
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 2015-03-20
Classification & Regulation
This clearance is catalogued under FDA product code LBI and 21 CFR 880.5700, within the General Hospital review panel as a Class II device.