The following data is part of a premarket notification filed by Edx Epi-scan, Inc. with the FDA for Epi-scan, Model P 100.
| Device ID | K032935 |
| 510k Number | K032935 |
| Device Name: | EPI-SCAN, MODEL P 100 |
| Classification | Device, Galvanic Skin Response Measurement |
| Applicant | EDX EPI-SCAN, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland EDX EPI-SCAN, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | GZO |
| CFR Regulation Number | 882.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2003-11-20 |
| Summary: | summary |