K953205 is an FDA 510(k) clearance for the CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION). This device is classified as a Stimulator, Nerve, Peripheral, Electric (Class II - Special Controls, product code KOI).
Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on May 23, 1996, 359 days after receiving the submission on May 30, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2775.
| 510(k) Number | K953205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1995 |
| Decision Date | May 23, 1996 |
| Days to Decision | 359 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | KOI — Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2775 |