K091163 is an FDA 510(k) clearance for the PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Fiab Spa (Firenze, IT). The FDA issued a Cleared decision on July 22, 2009, 91 days after receiving the submission on April 22, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K091163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2009 |
| Decision Date | July 22, 2009 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY - Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |