Clearance Summary
HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) received FDA 510(k) clearance under submission number K132036, sponsored by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-07-01.
- Submission: K132036
- Applicant / Sponsor: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2014-07-01
Classification & Regulation
This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.