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510(k) K241335

Device
Eversense 365 Continuous Glucose Monitoring (CGM) System
Applicant
Senseonics, Incorporated
510(k) number
K241335
Product code
SBA
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-16
Date received
2024-05-13
Regulation
862.1357
Classification name
Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mukul Jain
Address
20451 Seneca Meadows Pkwy. Germantown MD US 20876 20876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SBA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
DEN230052Eversense AP CGM SystemSenseonics, Incorporated2024-04-29