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FDA 510(k) Application Details - K221259
Device Classification Name
More FDA Info for this Device
510(K) Number
K221259
Device Name
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
Applicant
Dexcom, Inc.
6340 Sequence Dr.
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Rachel Ellena
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
05/02/2022
Decision Date
07/29/2022
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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