Panorama Patient Monitoring Network
FDA 510(k) clearance K150082 · decided 2015-09-02
Clearance details
- K-number
- K150082
- Device name
- Panorama Patient Monitoring Network
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-01-15
- Decision date
- 2015-09-02
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software recall (Z-0701-2016) | Mindray DS USA, Inc. dba Mindray North America | 2016-01-29 |