The following data is part of a premarket notification filed by Tandem Diabetes Care, Inc. with the FDA for Basal-iq Technology.
| Device ID | K193483 |
| 510k Number | K193483 |
| Device Name: | Basal-IQ Technology |
| Classification | Interoperable Automated Glycemic Controller, Insulin Suspend |
| Applicant | Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 |
| Contact | Trevor J Dendo |
| Correspondent | Trevor J Denbo Tandem Diabetes Care, Inc. 11075 Roselle Street San Diego, CA 92121 |
| Product Code | QJS |
| CFR Regulation Number | 862.1356 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-02-28 |