510(k) K173830 ยท DPS Electrocardiograph
MAC VU360 Resting ECG Analysis System
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Sep 18, 2018 |
| Received | Dec 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173830
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2026 | GE Medical Systems Information Technologies Inc GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph Open, Classified |
DPS | None listed |
| Oct 22, 2025 | GE Medical Systems, LLC MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4 Open, Classified |
DPS | None listed |
| Dec 7, 2020 | GE Healthcare, LLC MAC VU360, Electrocardiograph Terminated |
DPS | None listed |
| Jun 28, 2019 | GE Healthcare, LLC MAC VU360, Model Number 2030360-001, Electrocardiograph Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.