Clearance Summary
M SERIES PATIENT MONITOR received FDA 510(k) clearance under submission number K131876, sponsored by Mid-Link Consulting Co, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-02-27.
- Submission: K131876
- Applicant / Sponsor: Mid-Link Consulting Co, Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2014-02-27
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.