The following data is part of a premarket notification filed by Apex Medical Corp. with the FDA for Modification To:apex Medical If-4100.
| Device ID | K013813 |
| 510k Number | K013813 |
| Device Name: | MODIFICATION TO:APEX MEDICAL IF-4100 |
| Classification | Electrode, Cutaneous |
| Applicant | APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien, TW |
| Contact | Alan Change |
| Correspondent | Alan Change APEX MEDICAL CORP. 10TH FLOOR, NO.31, LANE 169 KANG NING STREET Hsi-chih City, Taipei Hsien, TW |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-16 |
| Decision Date | 2001-12-14 |