510(k) K171621 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
| Applicant | Welch Allyn, Inc., Skaneateles Falls NY, US |
| Decision | Substantially Equivalent, Jun 30, 2017 |
| Received | Jun 2, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Baxter Healthcare Corporation Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers:
1) 84MTVE2-4;
2) 84MTVE2-6;
3) 84MTVE2-B;
4) 84MTVE2-US;
5) 84MTVEC-6;
6) 84MTVEC-B;
7) 84MTVEP-B;
8) 84MTVEX-4;
9) 84MT Open, Classified |
DXQ | None listed |
| Apr 15, 2025 | Baxter Healthcare Corporation Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers:
1) 73WT-B;
2) 74CE-B;
3) 74CT-B;
4) 74CX-B;
5) 74ME-B;
6) 74MT-B;
7) 74MX-B;
8) 74RE-B;
9) 74RT-B;
10) 75CE-B;
11) Open, Classified |
MHX | None listed |
| Apr 14, 2025 | Baxter Healthcare Corporation Welch Allyn Connex Vital Signs Monitor (CVSM): Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.