510(k) K193483

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

February 28, 2020

Date Received

December 17, 2019

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Interoperable Automated Glycemic Controller, Insulin Suspend

Device Class

Class II

Regulation Number

862.1356

Review Panel

CH

Submission Type

An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.