Clearance Summary
REGIONAL ANAESTHESIA TRAY received FDA 510(k) clearance under submission number K932614, sponsored by Mediziv Medical Products , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1994-09-21.
- Submission: K932614
- Applicant / Sponsor: Mediziv Medical Products , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 1994-09-21
Classification & Regulation
This clearance is catalogued under FDA product code CAZ and 21 CFR 868.5140, within the Anesthesiology review panel as a Class II device.