510(k) K132036
K132036 is an FDA 510(k) premarket notification submitted by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. for the device "HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)". The FDA issued a decision of Substantially Equivalent on Jul 1, 2014. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 1, 2014
- Date Received
- Jul 1, 2013
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type
- 510(k)