The following data is part of a premarket notification filed by Sweetspot Diabetes Care, Inc. with the FDA for Sweetspot Diabetes Data Management Service.
| Device ID | K111509 |
| 510k Number | K111509 |
| Device Name: | SWEETSPOT DIABETES DATA MANAGEMENT SERVICE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | SWEETSPOT DIABETES CARE, INC. 2538 NE 48TH AVE Portland, OR 97213 -1924 |
| Contact | Chris Logan |
| Correspondent | Chris Logan SWEETSPOT DIABETES CARE, INC. 2538 NE 48TH AVE Portland, OR 97213 -1924 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-01 |
| Decision Date | 2011-11-09 |
| Summary: | summary |