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FDA 510(k) Application Details - K182405
Device Classification Name
More FDA Info for this Device
510(K) Number
K182405
Device Name
Dexcom Pro Q Continuous Glucose Monitoring System
Applicant
Dexcom, Inc
6310 Sequence Dr.
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Luke Olson
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QDL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/04/2018
Decision Date
11/02/2018
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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