510(k) K251591 ยท DQK Computer, Diagnostic, Programmable
Holter ECG and ABP system (HolterABP)
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Feb 9, 2026 |
| Received | May 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251591
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.