Clearance Summary
VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. received FDA 510(k) clearance under submission number K922997, sponsored by Via Medical 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 1994-01-11.
- Submission: K922997
- Applicant / Sponsor: Via Medical Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1994-01-11
Classification & Regulation
This clearance is catalogued under FDA product code LZF and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.