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FDA 510(k) Application Details - DEN170088
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN170088
Device Name
Dexcom G6 Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
6340 Sequence Dr
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Neeta Sharma
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QBJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/08/2017
Decision Date
03/27/2018
Decision
DENG -
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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