SmartBolus Calculator— 510(k) K222239
Substantially EquivalentInsulet Corporation
FDA 510(k) clearance K222239 for SmartBolus Calculator, Substantially Equivalent on 2022-08-19. Applicant: Insulet Corporation. Device class: 2.
Clearance details
- Applicant
- Insulet Corporation
- 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
- Acton, MA, US
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