The following data is part of a premarket notification filed by Delsys, Inc. with the FDA for The Bagnoli-2 Emg System.
| Device ID | K945286 |
| 510k Number | K945286 |
| Device Name: | THE BAGNOLI-2 EMG SYSTEM |
| Classification | Device, Biofeedback |
| Applicant | DELSYS, INC. 30 YARMOUTH ROAD Wellesley, MA 02181 |
| Contact | Carlo J De Luca |
| Correspondent | Carlo J De Luca DELSYS, INC. 30 YARMOUTH ROAD Wellesley, MA 02181 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-31 |
| Decision Date | 1995-09-15 |