The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Sls 3500 Led Visual Stimulator.
| Device ID | K842381 |
| 510k Number | K842381 |
| Device Name: | SLS 3500 LED VISUAL STIMULATOR |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | NIHON KOHDEN AMERICA, INC. 1652 DEERE AVENUE Irvine , CA 92714 - |
| Contact | Paul M Parashak |
| Correspondent | Paul M Parashak NIHON KOHDEN AMERICA, INC. 1652 DEERE AVENUE Irvine , CA 92714 - |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-18 |
| Decision Date | 1984-11-09 |