Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor— 510(k) K172649
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K172649 for Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor, Substantially Equivalent on 2017-11-01. Applicant: Heidelberg Engineering GmbH.
Clearance details
- Applicant
- Heidelberg Engineering GmbH
- Product code
- Code OBO
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Heidelberg, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.