The following data is part of a premarket notification filed by Stockert Gmbh with the FDA for Modification To Stimuplex Hns-12, Model 4892098.
| Device ID | K070134 |
| 510k Number | K070134 |
| Device Name: | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | STOCKERT GMBH BOETZINGER STRASSE 72 Freiburg, B-w, DE D-79111 |
| Contact | Dominika Schuler |
| Correspondent | Dominika Schuler STOCKERT GMBH BOETZINGER STRASSE 72 Freiburg, B-w, DE D-79111 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-03-22 |
| Summary: | summary |