510(k) K230184 ยท DSH Recorder, Magnetic Tape, Medical
Holter ECG and ABP System
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 25, 2023 |
| Received | Jan 23, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230184
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.