The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Ministim Ms-ivb Peripheral Nerve Stimulator.
| Device ID | K143095 |
| 510k Number | K143095 |
| Device Name: | MiniStim MS-IVB Peripheral Nerve Stimulator |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | Halyard Health, Inc. 1400 Holcomb Bridge Road Roswell, GA 30076 |
| Contact | Lindsey Hedlund |
| Correspondent | Lindsey Hedlund Halyard Health, Inc. 1400 Holcomb Bridge Road Roswell, GA 30076 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-28 |
| Decision Date | 2015-03-24 |
| Summary: | summary |