Clearance Summary
ALLTEK BROMPTON ENCODER received FDA 510(k) clearance under submission number K820145, sponsored by Alltek Hospital Supplies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1982-03-02.
- Submission: K820145
- Applicant / Sponsor: Alltek Hospital Supplies , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2330
- Decision date: 1982-03-02
Classification & Regulation
This clearance is catalogued under FDA product code DXK and 21 CFR 870.2330, within the Cardiovascular review panel as a Class II device.