ClearanceBrief
510(k) K173648 ยท OBO Tomography, Optical Coherence

Spectralis HRA + OCT and variants

ApplicantHeidelberg Engineering GmbH, Heidelberg, DE
DecisionSubstantially Equivalent, Aug 30, 2018
ReceivedNov 27, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K173648

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.