The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Sen-4100 Electric Stimulator.
| Device ID | K071969 |
| 510k Number | K071969 |
| Device Name: | SEN-4100 ELECTRIC STIMULATOR |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Jack Coggan |
| Correspondent | Jack Coggan NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-17 |
| Decision Date | 2008-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921887981 | K071969 | 000 |
| 04931921105313 | K071969 | 000 |
| 00841983102318 | K071969 | 000 |
| 00841983101427 | K071969 | 000 |