The following data is part of a premarket notification filed by Tandem Diabetes Care, Inc. with the FDA for T:connect Data Management System.
| Device ID | K122361 |
| 510k Number | K122361 |
| Device Name: | T:CONNECT DATA MANAGEMENT SYSTEM |
| Classification | Medical Device Data System |
| Applicant | TANDEM DIABETES CARE, INC. 11045 Roselle St Ste 200 San Diego, CA 92121 |
| Contact | Don Canal |
| Correspondent | Don Canal TANDEM DIABETES CARE, INC. 11045 Roselle St Ste 200 San Diego, CA 92121 |
| Product Code | OUG |
| CFR Regulation Number | 880.6310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-03 |
| Decision Date | 2013-02-22 |
| Summary: | summary |