Clearance Summary
The Belmont Hyperthermia Pump received FDA 510(k) clearance under submission number K152208, sponsored by Belmont Instrument Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2015-09-02.
- Submission: K152208
- Applicant / Sponsor: Belmont Instrument Corporation
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2015-09-02
Classification & Regulation
This clearance is catalogued under FDA product code LGZ and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.