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FDA 510(k) Application Details - K231081
Device Classification Name
More FDA Info for this Device
510(K) Number
K231081
Device Name
Dexcom G7 Continuous Glucose Monitoring (CGM) System
Applicant
Dexcom, Inc.
6340 Sequence Dr
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Bob Shen
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QBJ
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More FDA Info for this Product Code
Date Received
04/17/2023
Decision Date
05/15/2023
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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