Spectralis HRA+OCT and variants with High Magnification Module— 510(k) K182569
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K182569 for Spectralis HRA+OCT and variants with High Magnification Module, Substantially Equivalent on 2018-10-18. 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.