The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Constant Current Peripheral Nerve Stimulator Ns272 (modification).
| Device ID | K953205 |
| 510k Number | K953205 |
| Device Name: | CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Contact | Chris Mander |
| Correspondent | Chris Mander FISHER & PAYKEL HEALTHCARE, LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-30 |
| Decision Date | 1996-05-23 |
| Summary: | summary |