BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
FDA 510(k) clearance K092449 · decided 2010-08-30
Clearance details
- K-number
- K092449
- Device name
- BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-10
- Decision date
- 2010-08-30
- Days to decision
- 385 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- 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 DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alar recall (Z-2737-2015) | Mindray DS USA, Inc. dba Mindray North America | 2015-09-04 |
| DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP m recall (Z-0837-2015) | Mindray DS USA, Inc. dba Mindray North America | 2014-12-19 |
| DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitor recall (Z-1611-2014) | Mindray DS USA, Inc. dba Mindray North America | 2014-05-13 |
| DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blv recall (Z-0513-2013) | Mindray DS USA, Inc. d.b.a. Mindray North America | 2012-12-11 |