The following data is part of a premarket notification filed by Delsys, Inc. with the FDA for The Bagnoli-8 Emg System.
| Device ID | K990356 |
| 510k Number | K990356 |
| Device Name: | THE BAGNOLI-8 EMG SYSTEM |
| Classification | Device, Biofeedback |
| Applicant | DELSYS, INC. PO BOX 15734 Boston, MA 02215 |
| Contact | Gianluca De Luca |
| Correspondent | Gianluca De Luca DELSYS, INC. PO BOX 15734 Boston, MA 02215 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-05 |
| Decision Date | 1999-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851679007056 | K990356 | 000 |
| 00851679007049 | K990356 | 000 |
| 00851679007032 | K990356 | 000 |
| 00851679007025 | K990356 | 000 |
| 00851679007018 | K990356 | 000 |