The following data is part of a premarket notification filed by Halyard Health - Irvine with the FDA for Ezstim*iii Peripheral Nerve Stimulator/nerve Locator.
| Device ID | K162048 |
| 510k Number | K162048 |
| Device Name: | EZstim*III Peripheral Nerve Stimulator/Nerve Locator |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | HALYARD HEALTH - IRVINE 43 DISCOVERY, SUITE 100 Irvine, CA 92618 |
| Contact | Maria Pronina |
| Correspondent | Maria Pronina HALYARD HEALTH - IRVINE 43 DISCOVERY, SUITE 100 Irvine, CA 92618 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-25 |
| Decision Date | 2016-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651447365 | K162048 | 000 |
| 30680651447358 | K162048 | 000 |
| 30680651392535 | K162048 | 000 |
| 00193494447366 | K162048 | 000 |
| 00193494447359 | K162048 | 000 |
| 00193494392536 | K162048 | 000 |