510(k) K191013 ยท BZG Spirometer, Diagnostic
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
| Applicant | Welch Allyn, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 10, 2019 |
| Received | Apr 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191013
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2024 | Baxter Healthcare Corporation Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer Open, Classified |
BZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.