BlueStar CGM insulin dose calculator— 510(k) K222888
Substantially EquivalentWelldoc, Inc.
FDA 510(k) clearance K222888 for BlueStar CGM insulin dose calculator, Substantially Equivalent on 2023-08-11. Applicant: Welldoc, Inc.. Device class: 2.
Clearance details
- Applicant
- Welldoc, Inc.
- Product code
- Code QRX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1358
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
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