FDA.report

510(k) K203689

Device
Tidepool Loop
Applicant
Tidepool Project
510(k) number
K203689
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-23
Date received
2020-12-17
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
No

Related Records

Applicant Contact

Contact
Howard Look
Address
3340 Hillview Ave. Palo Alto CA US 94304 94304

FDA Registration Numbers

Source Documents

510(k) summary PDF

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