ClearanceBrief
510(k) K212830 ยท FEN Device, Cystometric, Hydraulic

CT3000Pro

ApplicantSrs Medical, North Billerica MA, US
DecisionSubstantially Equivalent, Dec 21, 2021
ReceivedSep 7, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K212830

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.