The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Es2 Neuromonitoring Accessory Instruments.
| Device ID | K140400 |
| 510k Number | K140400 |
| Device Name: | ES2 NEUROMONITORING ACCESSORY INSTRUMENTS |
| Classification | Stimulator, Nerve |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Soraya King |
| Correspondent | Soraya King STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-07-01 |
| Summary: | summary |