FDA.report

510(k) K251217

Device
SmartGuard technology; Predictive Low Glucose technology
Applicant
Medtronic Minimed, Inc.
510(k) number
K251217
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-29
Date received
2025-04-21
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
N

Related Records

Applicant Contact

Contact
Hemang Kotecha
Address
18000 Devonshire St. Northridge CA US 91325 91325

FDA Registration Numbers

Source Documents

510(k) summary PDF

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