N Series Patient Monitors
FDA 510(k) clearance K213799 · decided 2022-07-12
Clearance details
- K-number
- K213799
- Device name
- N Series Patient Monitors
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-06
- Decision date
- 2022-07-12
- Days to decision
- 218 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 |
|---|---|---|
| BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00 recall (Z-2622-2025) | Mindray DS USA, Inc. dba Mindray North America | 2025-09-25 |