510(k) K142356 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Connex Spot Monitor,901058 Vital Signs Monitor Core
| Applicant | Welch Allyn, Inc., Skaneateles Falls NY, US |
| Decision | Substantially Equivalent, Dec 19, 2014 |
| Received | Aug 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142356
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Baxter Healthcare Corporation Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers:
1) ) Product Code/Part # 67MXTP-B-ECG3A;
2) ) Product Code/Part # 67MXTX-B;
3) ) Product Code/Part # 67MXXP-B;
4) ) Product Code Open, Classified |
DXQ | None listed |
| Apr 15, 2025 | Baxter Healthcare Corporation Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers:
1) 44WT-2;
2) 44WT-3;
3) 44WT-4;
4) 44WT-6;
5) 44WT-B;
6) 44XT-2;
7) 44XT-4;
8) 44XT-6;
9) 44XT-B. Open, Classified |
MWI | None listed |
| Sep 12, 2023 | Baxter Healthcare Corporation Welch Allyn Connex Spot Monitor Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.