Clearance Summary
HR 100T received FDA 510(k) clearance under submission number K831955, sponsored by Thought Technology , 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 1983-08-11.
- Submission: K831955
- Applicant / Sponsor: Thought Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2780
- Decision date: 1983-08-11
Classification & Regulation
This clearance is catalogued under FDA product code JOM and 21 CFR 870.2780, within the Cardiovascular review panel as a Class II device.