Spectralis HRA+OCT and variants with OCT Angiography Module— 510(k) K181594
Substantially EquivalentHeidelberg Engineering GmbH
FDA 510(k) clearance K181594 for Spectralis HRA+OCT and variants with OCT Angiography Module, Substantially Equivalent on 2018-09-13. Applicant: Heidelberg Engineering GmbH. Device class: 2.
Clearance details
- Applicant
- Heidelberg Engineering GmbH
- 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
- Heidelberg, DE
Recent devices under product code OBO
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view allRecalls naming K181594
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181594.
Data sourced from openFDA. This site is unofficial and independent of the FDA.