Panorama Patient Monitoring Network
FDA 510(k) clearance K142601 · decided 2014-11-14
Clearance details
- K-number
- K142601
- Device name
- Panorama Patient Monitoring Network
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-11
- Decision date
- 2014-11-14
- Days to decision
- 64 days
- Clearance type
- Abbreviated
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nasham, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Det recall (Z-1675-2015) | Mindray DS USA, Inc. dba Mindray North America | 2015-05-26 |