510(k) DEN190034
DEN190034 is an FDA 510(k) premarket notification submitted by Tandem Diabetes Care, Inc. for the device "Control-IQ Technology". The FDA issued a decision of De Novo Granted on December 13, 2019. The device falls under product code QJI (Interoperable Automated Glycemic Controller), a Class II device regulated under 21 CFR 862.1356. Tandem Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.
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.