510(k) K193483
K193483 is an FDA 510(k) premarket notification submitted by Tandem Diabetes Care, Inc. for the device "Basal-IQ Technology". The FDA issued a decision of Substantially Equivalent on February 28, 2020. The device falls under product code QJS (Interoperable Automated Glycemic Controller, Insulin Suspend), 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
- 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.