The following data is part of a premarket notification filed by Fisher & Paykel Allied Products Ltd. with the FDA for Peripheral Nerve Stimulator Model A400.
| Device ID | K852962 |
| 510k Number | K852962 |
| Device Name: | PERIPHERAL NERVE STIMULATOR MODEL A400 |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | FISHER & PAYKEL ALLIED PRODUCTS LTD. 25 CARBINE ROAD, PANMURE P.O. BOX 14-348, PANMURE Auckland, New Zealand, NZ |
| Contact | Dave Milburn |
| Correspondent | Dave Milburn FISHER & PAYKEL ALLIED PRODUCTS LTD. 25 CARBINE ROAD, PANMURE P.O. BOX 14-348, PANMURE Auckland, New Zealand, NZ |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-12 |
| Decision Date | 1985-12-09 |