The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Es2 Neuromonitoring Accessory Instruments.
| Device ID | K171807 |
| 510k Number | K171807 |
| Device Name: | ES2 Neuromonitoring Accessory Instruments |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
| Contact | Nikin Desai |
| Correspondent | Nikin Desai Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-19 |
| Decision Date | 2017-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327359619 | K171807 | 000 |
| 07613327359596 | K171807 | 000 |
| 07613327359589 | K171807 | 000 |
| 07613327359572 | K171807 | 000 |