510(k) K172862 ยท DSH Recorder, Magnetic Tape, Medical
Portable ECG Monitor (ECG3)
| Applicant | Andon Health Co, Ltd., Tianjin, CN |
| Decision | Substantially Equivalent, Jul 24, 2018 |
| Received | Sep 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172862
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.