HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
FDA 510(k) clearance K080192 · decided 2008-04-03
Clearance details
- K-number
- K080192
- Device name
- HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS)
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-25
- Decision date
- 2008-04-03
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- MSX
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers recall (Z-0798-2013) | Mindray DS USA, Inc. d.b.a. Mindray North America | 2013-02-11 |
| DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Cen recall (Z-0630-2013) | Mindray DS USA, Inc. d.b.a. Mindray North America | 2013-01-03 |