510(k) K253293 ยท DSH Recorder, Magnetic Tape, Medical
VitaloJAK Clinic (Model 7100)
| Applicant | Vitalograph , Ltd., Ennis Co. Clare, IE |
| Decision | Substantially Equivalent, Dec 3, 2025 |
| Received | Sep 29, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253293
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.