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FDA 510(k) Application Details - K222239
Device Classification Name
More FDA Info for this Device
510(K) Number
K222239
Device Name
SmartBolus Calculator
Applicant
Insulet Corporation
100 Nagog Park
Acton, MA 01720 US
Other 510(k) Applications for this Company
Contact
Alexander Hamad
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/26/2022
Decision Date
08/19/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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