510(k) K192391 · OBO Tomography, Optical Coherence

Spectralis HRA+OCT and Variants

Applicant	Heidelberg Engineering GmbH, Heidelberg, DE
Decision	Substantially Equivalent, Sep 26, 2019
Received	Sep 3, 2019
Type	Special
FDA record	Open on fda.gov

Recalls that name K192391

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.