FDA.report

510(k) K252770

Device
iLet ACE Pump
Applicant
Beta Bionics, Inc.
510(k) number
K252770
Product code
QFG
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-29
Date received
2025-09-02
Regulation
880.5730
Classification name
Alternate Controller Enabled Insulin Infusion Pump
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Liz Cooper
Address
300 Baker Ave., Suite 301 Concord MA US 01742 01742

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QFG

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