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FDA 510(k) Application Details - K193483
Device Classification Name
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510(K) Number
K193483
Device Name
Basal-IQ Technology
Applicant
Tandem Diabetes Care, Inc.
11075 Roselle Street
San Diego, CA 92121 US
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Contact
Trevor J Dendo
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Regulation Number
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Classification Product Code
QJS
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More FDA Info for this Product Code
Date Received
12/17/2019
Decision Date
02/28/2020
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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