FDA.report

510(k) K250798

Device
Control-IQ+ technology
Applicant
Tandem Diabetes Care, Inc.
510(k) number
K250798
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-21
Date received
2025-03-14
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
Miriam Chan
Address
12400 High Bluff Dr. San Diego CA US 92130 92130

FDA Registration Numbers

Source Documents

510(k) summary PDF

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