Clearance Summary
SYRINGE PUMP: VM 07 received FDA 510(k) clearance under submission number K860218, sponsored by Vial Medical , 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 1986-04-07.
- Submission: K860218
- Applicant / Sponsor: Vial Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1986-04-07
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.