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. Device class: 2.
Clearance details
- Applicant
- Heidelberg Engineering
- Product code
- Code OBO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code OBO
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