Spectralis HRA + OCT and variants— 510(k) K173648
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K173648 for Spectralis HRA + OCT and variants, Substantially Equivalent on 2018-08-30. 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.