The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Constant Current Peripheral Nerve Stim. #ns252.
| Device ID | K882438 |
| 510k Number | K882438 |
| Device Name: | CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252 |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | David Milburn |
| Correspondent | David Milburn FISHER & PAYKEL HEALTHCARE, 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 | 1988-06-14 |
| Decision Date | 1988-07-18 |