FDA 510(k) Application Details - K220916

Device Classification Name

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510(K) Number K220916
Device Name iLet« Dosing Decision Software
Applicant Beta Bionics, Inc.
300 Baker Ave Ste 301
Concord, MA 01742-2131 US
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Contact Vikram Verma
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Regulation Number

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Classification Product Code QJI
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Date Received 03/30/2022
Decision Date 05/19/2023
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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