510(k) K201252 · OBO Tomography, Optical Coherence

Spectralis HRA+OCT and variants

Applicant	Heidelberg Engineering GmbH, Heidelberg, DE
Decision	Substantially Equivalent, Sep 9, 2020
Received	May 11, 2020
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K201252

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.