K013813 is an FDA 510(k) clearance for the MODIFICATION TO:APEX MEDICAL IF-4100. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on December 14, 2001, 28 days after receiving the submission on November 16, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K013813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2001 |
| Decision Date | December 14, 2001 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |