DeviceClearance

BlueStar CGM insulin dose calculator— 510(k) K222888

Substantially Equivalent

Welldoc, Inc.

FDA 510(k) clearance K222888 for BlueStar CGM insulin dose calculator, Substantially Equivalent on 2023-08-11. Applicant: Welldoc, Inc..

Clearance details

Applicant
Welldoc, Inc.
Product code
Code QRX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Columbia, MD, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.