Clearance Summary
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 received FDA 510(k) clearance under submission number K012712, sponsored by Norav Medical , 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 2002-05-08.
- Submission: K012712
- Applicant / Sponsor: Norav Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2002-05-08
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.