FDA.report

510(k) K232741

Device
SmartAdjust(TM) technology
Applicant
Insulet Corporation
510(k) number
K232741
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-29
Date received
2023-09-07
Regulation
862.1356
Classification name
Interoperable Automated Glycemic Controller
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Alexander Hamad
Address
100 Nagog Park Acton MA US 02144 02144

FDA Registration Numbers

Source Documents

510(k) summary PDF

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