The following data is part of a premarket notification filed by Technomed Europe with the FDA for Surgical Stimulators.
| Device ID | K110422 |
| 510k Number | K110422 |
| Device Name: | SURGICAL STIMULATORS |
| Classification | Stimulator, Nerve |
| Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Contact | Pierre Vreuls |
| Correspondent | Pierre Vreuls TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-05-26 |
| Summary: | summary |