The following data is part of a premarket notification filed by Prodigy Diabetes Care, Llc. with the FDA for Prodigy Diabetes Management Software.
| Device ID | K103115 |
| 510k Number | K103115 |
| Device Name: | PRODIGY DIABETES MANAGEMENT SOFTWARE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | PRODIGY DIABETES CARE, LLC. 1468 Harwell Avenue Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith PRODIGY DIABETES CARE, LLC. 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-21 |
| Decision Date | 2011-10-12 |
| Summary: | summary |