Clearance Summary
BED-CHECK: II-IFAC received FDA 510(k) clearance under submission number K823926, sponsored by Bed-Check Corp.. 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 1983-04-18.
- Submission: K823926
- Applicant / Sponsor: Bed-Check Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.2400
- Decision date: 1983-04-18
Classification & Regulation
This clearance is catalogued under FDA product code KMI and 21 CFR 880.2400, within the General Hospital review panel as a Class I device.