ClearanceBrief
510(k) K213137 ยท IYE Accelerator, Linear, Medical

INTDose

ApplicantCarina Medical, LLC, Lexington KY, US
DecisionSubstantially Equivalent, May 13, 2022
ReceivedSep 27, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K213137

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.