Omnipod 5 SmartBolus Calculator— 510(k) K203772

Substantially Equivalent

Insulet Corporation

FDA 510(k) clearance K203772 for Omnipod 5 SmartBolus Calculator, Substantially Equivalent on 2022-01-27. Applicant: Insulet Corporation.

Clearance details

Applicant
Insulet Corporation
Product code
Code QRX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Acton, MA, US
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