Clearance Summary
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 received FDA 510(k) clearance under submission number K024323, sponsored by Biomedical Systems Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-06-30.
- Submission: K024323
- Applicant / Sponsor: Biomedical Systems Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2003-06-30
Classification & Regulation
This clearance is catalogued under FDA product code MLO and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.