FDA.report

510(k) K234027

Device
embecta Insulin Delivery System
Applicant
Embecta Medical I, LLC
510(k) number
K234027
Product code
QFG
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-30
Date received
2023-12-20
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
Andrew Harrell
Address
200 Bulfinch Dr., Suite 100 Andover MA US 01810 01810

FDA Registration Numbers

Source Documents

510(k) summary PDF

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