510(k) K180432 ยท DQK Computer, Diagnostic, Programmable
AI-ECG Platform
| Applicant | Shenzhen Carewell Electronics., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Nov 19, 2018 |
| Received | Feb 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180432
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.