510(k) K221321 ยท DPS Electrocardiograph
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Oct 18, 2022 |
| Received | May 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221321
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2026 | GE Medical Systems China Co., Ltd. MAC 5 A4 Resting ECG Analysis System 855001-001;
MAC 5 A5 Resting ECG Analysis System 8855002-001.
Electrocardiograph Open, Classified |
DXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.