FDA.report

510(k) K231826

Device
Omnipod 5 ACE Pump
Applicant
Insulet Corporation
510(k) number
K231826
Product code
QFG
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-18
Date received
2023-06-21
Regulation
880.5730
Classification name
Alternate Controller Enabled Insulin Infusion Pump
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
Maria Brower
Address
100 Nagog Park Acton MA US 01720 01720

FDA Registration Numbers

Source Documents

510(k) summary PDF

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