FDA.reportPublic FDA data

510(k) K241078

Device
Tandem Mobi Insulin Pump with interoperable technology
Applicant
Tandem Diabetes Care, Inc.
510(k) number
K241078
Product code
QFG
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-26
Date received
2024-04-19
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

Applicant Contact#

Contact
Jordan Barkhimer
Address
12400 High Bluff Dr. San Diego CA US 92130 92130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QFG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K240309Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.2024-03-21
K233952DEKA ACE Pump SystemDeka Research and Development2024-03-13
K230545Inessa SystemTriple Jump Israel , Ltd.2023-12-20
K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.2023-11-03
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