Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor— 510(k) K152205
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K152205 for Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor, Substantially Equivalent on 2016-05-06. 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
- Traditional
- Location
- Heidelberg, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.