510(k) clearance
iOS CamAPS FX
- 510(k) number
- K261896
- Applicant
- CamDiab
- Decision date
- Sep 16, 2026
- Date received
- Jun 8, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QJI
- Device type
- Interoperable Automated Glycemic Controller
- Device class
- Class II
- Regulation
- 21 CFR 862.1356
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- London, GB