Clearance Summary
HOLTER 2000 received FDA 510(k) clearance under submission number K990170, sponsored by Zymed Medical Instrumentation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-04-13.
- Submission: K990170
- Applicant / Sponsor: Zymed Medical Instrumentation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1999-04-13
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.