Clearance Summary
VITALOGRAPH MODEL 7100 - VITALOJAK received FDA 510(k) clearance under submission number K110525, sponsored by Vitalograph (Ireland) , 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 2011-11-23.
- Submission: K110525
- Applicant / Sponsor: Vitalograph (Ireland) , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2011-11-23
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.