V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
FDA 510(k) clearance K132026 · decided 2013-12-20
Clearance details
- K-number
- K132026
- Device name
- V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
- Applicant
- Mindray DS USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-01
- Decision date
- 2013-12-20
- Days to decision
- 172 days
- Clearance type
- Abbreviated
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mahwh, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series M recall (Z-0107-2015) | Mindray DS USA, Inc. dba Mindray North America | 2014-10-21 |