510(k) clearance
iLet Dosing Decision Software
- 510(k) number
- K262763
- Applicant
- Beta Bionics, Inc.
- Decision date
- Sep 11, 2026
- Date received
- Aug 4, 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
- Irvine, CA, US