Clearance Summary
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 received FDA 510(k) clearance under submission number K993643, sponsored by Nexan Telemed , 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 1999-12-28.
- Submission: K993643
- Applicant / Sponsor: Nexan Telemed , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1999-12-28
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.