The following data is part of a premarket notification filed by Agamatrix with the FDA for Wavesense Diabetes Manager Model Version 1.3.4.
| Device ID | K101597 |
| 510k Number | K101597 |
| Device Name: | WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | AGAMATRIX 10 MAOR PARKWAY Salem, NH 03079 |
| Contact | Connie Hertel |
| Correspondent | Connie Hertel AGAMATRIX 10 MAOR PARKWAY Salem, NH 03079 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-08 |
| Decision Date | 2010-10-18 |
| Summary: | summary |