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510(k) K193483

Device
Basal-IQ Technology
Applicant
Tandem Diabetes Care, Inc.
510(k) number
K193483
Product code
QJS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-28
Date received
2019-12-17
Regulation
862.1356
Classification name
Interoperable Automated Glycemic Controller, Insulin Suspend
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
Trevor J Dendo
Address
11075 Roselle St. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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