SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT— 510(k) K121993
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K121993 for SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT, Substantially Equivalent on 2012-10-25. 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
- Fairfax, VA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.