K240221
- 510(k) number
- K240221
- Device name
- SPECTRALIS HRA+OCT and variants
- Applicant
- Heidelberg Engineering GmbH DE
- Product code
- OBO — Tomography, Optical Coherence
- Decision date
- 2024-07-01
- Date received
- 2024-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K240221.pdf
Official FDA record: K240221
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.