The following data is part of a premarket notification filed by Stockert Gmbh with the FDA for Stimuplex Hns-11.
| Device ID | K003983 |
| 510k Number | K003983 |
| Device Name: | STIMUPLEX HNS-11 |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | STOCKERT GMBH BOTZINGER STRABE 72 Freiburg, DE D-79111 |
| Contact | Dominika Schuler |
| Correspondent | Dominika Schuler STOCKERT GMBH BOTZINGER STRABE 72 Freiburg, DE D-79111 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-06-06 |