FDA.report

510(k) K234055

Device
DEKA Loop
Applicant
Deka Research and Development
510(k) number
K234055
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-13
Date received
2023-12-22
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
Paul Smolenski
Address
340 Commercial St. Manchester NH US 03101 03101

FDA Registration Numbers

Source Documents

510(k) summary PDF

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