K232603
- 510(k) number
- K232603
- Device name
- CamAPS FX
- Applicant
- Camdiab , Ltd. GB
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2024-05-23
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K232603
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.