HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016)— 510(k) K132036
Substantially EquivalentShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
FDA 510(k) clearance K132036 for HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016), Substantially Equivalent on 2014-07-01. Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
- Product code
- Code MSX
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mahwh, NJ, US
Recent devices under product code MSX
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- K171233 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Adverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.