ClearanceBrief
510(k) K233855 ยท BWF Spirometer, Therapeutic (Incentive)

AllPEP

ApplicantEnchant Tek Co. , Ltd., Yilan County, TW
DecisionSubstantially Equivalent, Feb 2, 2024
ReceivedDec 5, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K233855

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.