Clearance Summary
PATIENT TROLLEY 545 received FDA 510(k) clearance under submission number K943528, 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 1994-10-04.
- Submission: K943528
- Applicant / Sponsor: Merivaara Instrumentarium Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6910
- Decision date: 1994-10-04
Classification & Regulation
This clearance is catalogued under FDA product code FPO and 21 CFR 880.6910, within the General Hospital review panel as a Class II device.