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FDA 510(k) Application Details - K223931
Device Classification Name
More FDA Info for this Device
510(K) Number
K223931
Device Name
Dexcom G6 Continuous Glucose Monitoring (CGM) System
Applicant
Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 US
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Contact
Brittney Shaver
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QBJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/2022
Decision Date
01/11/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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