iLet® ACE Pump — Beta Bionics, Inc. (510(k) K223846)
iLet® ACE Pump — Beta Bionics, Inc. (510(k) K223846) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: iLet® ACE Pump; Applicant: Beta Bionics, Inc.; Clearance track: 510(k).
| Device name | iLet® ACE Pump |
|---|---|
| Applicant | Beta Bionics, Inc. |
| Clearance track | 510(k) |
| Submission number | K223846 |
| Decision | Substantially Equivalent |
| Decision date | 2023-05-19 |
| Date received | 2022-12-20 |
| Product code | QFG |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | MA, US |
| Source | openFDA device |
🔍 Search all device clearances →
$1999/mo
Try DeviceClear →