Clearance Summary
OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905) received FDA 510(k) clearance under submission number K944929, sponsored by Merivaara Instrumentarium 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 1994-11-22.
- Submission: K944929
- Applicant / Sponsor: Merivaara Instrumentarium Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5110
- Decision date: 1994-11-22
Classification & Regulation
This clearance is catalogued under FDA product code FNK and 21 CFR 880.5110, within the General Hospital review panel as a Class I device.