ClearanceBrief
510(k) K200980 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic

Auto 3D Bladder Volume Tool

ApplicantButterfly Network, Inc., Guildford CT, US
DecisionSubstantially Equivalent, Jun 11, 2020
ReceivedApr 14, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K200980

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.