510(k) DEN190034

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

December 13, 2019

Date Received

July 15, 2019

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Interoperable Automated Glycemic Controller

Device Class

Class II

Regulation Number

862.1356

Review Panel

CH

Submission Type

An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.