Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
FDA 510(k) clearance K171621 · decided 2017-06-30
Clearance details
- K-number
- K171621
- Device name
- Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-02
- Decision date
- 2017-06-30
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Skaneateles Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84M recall (Z-1562-2025) | Baxter Healthcare Corporation | 2025-04-15 |
| Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74C recall (Z-1563-2025) | Baxter Healthcare Corporation | 2025-04-15 |
| Welch Allyn Connex Vital Signs Monitor (CVSM): recall (Z-1558-2025) | Baxter Healthcare Corporation | 2025-04-14 |