Clearance Summary
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER received FDA 510(k) clearance under submission number K041901, sponsored by North East Monitoring, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-08-31.
- Submission: K041901
- Applicant / Sponsor: North East Monitoring, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2004-08-31
Classification & Regulation
This clearance is catalogued under FDA product code MWJ and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.