The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Model Ns242 Constant Current Peripheral Nerve Stim.
| Device ID | K883868 |
| 510k Number | K883868 |
| Device Name: | MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | David Milburn |
| Correspondent | David Milburn FISHER & PAYKEL ELECTRONICS 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 | 1988-09-13 |
| Decision Date | 1988-11-28 |