Clearance Summary
NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS received FDA 510(k) clearance under submission number K050800, sponsored by Caesarea Medical Electronics , Ltd.. 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 2005-11-23.
- Submission: K050800
- Applicant / Sponsor: Caesarea Medical Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2005-11-23
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.