FDA.reportPublic FDA data

510(k) K222888

Device
BlueStar CGM insulin dose calculator
Applicant
Welldoc, Inc.
510(k) number
K222888
Product code
QRX
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-11
Date received
2022-09-23
Regulation
862.1358
Classification name
Continuous Glucose Monitor Informed Insulin Dose Calculator
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
Ian Cadieux
Address
10221 Wincopin Cir., Suite 150 Columbia MD US 21044 21044

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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