510(k) K172649 · OBO Tomography, Optical Coherence

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor

Applicant	Heidelberg Engineering GmbH, Heidelberg, DE
Decision	Substantially Equivalent, Nov 1, 2017
Received	Sep 5, 2017
Type	Special
FDA record	Open on fda.gov

Recalls that name K172649

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.