Clearance Summary
Remunity System received FDA 510(k) clearance under submission number K243354, sponsored by Deka Research & Development Corp.. 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 2024-11-27.
- Submission: K243354
- Applicant / Sponsor: Deka Research & Development Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2024-11-27
Classification & Regulation
This clearance is catalogued under FDA product code QJY and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.