The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Stimulator Model Sss-1101.
| Device ID | K791149 |
| 510k Number | K791149 |
| Device Name: | STIMULATOR MODEL SSS-1101 |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-15 |
| Decision Date | 1979-09-17 |