Clearance Summary
VITALOGRAPH 2110 SOFTWARE INTERFACE received FDA 510(k) clearance under submission number K950854, sponsored by Vitalograph , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-10-12.
- Submission: K950854
- Applicant / Sponsor: Vitalograph , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1995-10-12
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.