The following data is part of a premarket notification filed by Natural Herbal Products, Inc. with the FDA for E-reader.
| Device ID | K970436 |
| 510k Number | K970436 |
| Device Name: | E-READER |
| Classification | Device, Galvanic Skin Response Measurement |
| Applicant | NATURAL HERBAL PRODUCTS, INC. 724 WIGGINS BAY DR. NAPLES, FL 34110 |
| Product Code | GZO |
| CFR Regulation Number | 882.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-05 |
| Decision Date | 1997-08-15 |