SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA— 510(k) K101223
Substantially EquivalentHeidelberg Engineering
FDA 510(k) clearance K101223 for SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA, Substantially Equivalent on 2010-10-01. Applicant: Heidelberg Engineering.
Clearance details
- Applicant
- Heidelberg Engineering
- Product code
- Code OBO
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.