510(k) K214125 ยท ONO Neurosurgical Laser With Mr Thermography
TRANBERG Thermoguide Therapy System
| Applicant | Clinical Laserthermia Systems, AB, Lund, SE |
| Decision | Substantially Equivalent, Sep 22, 2022 |
| Received | Dec 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214125
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.