K231820
- 510(k) number
- K231820
- Device name
- SoloSmart Injection Pen Adapter (SoloSmart®)
- Applicant
- Biocorp Production FR
- Product code
- QOG — Injection Data Capture Device
- Decision date
- 2024-01-12
- Date received
- 2023-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231820.pdf
Official FDA record: K231820
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.