The following data is part of a premarket notification filed by Nicolet Instrument Corp. with the FDA for Nicolet Viking Ii System.
| Device ID | K890495 |
| 510k Number | K890495 |
| Device Name: | NICOLET VIKING II SYSTEM |
| Classification | Electromyograph, Diagnostic |
| Applicant | NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle NICOLET INSTRUMENT CORP. 5225 VERONA RD. Madison, WI 53711 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-01 |
| Decision Date | 1989-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830043595 | K890495 | 000 |
| 00382830035910 | K890495 | 000 |
| 00382830035903 | K890495 | 000 |
| 00382830034654 | K890495 | 000 |
| 00382830034647 | K890495 | 000 |
| 00382830034630 | K890495 | 000 |
| 00382830034623 | K890495 | 000 |
| 00382830034500 | K890495 | 000 |
| 00382830034494 | K890495 | 000 |
| 00382830035927 | K890495 | 000 |
| 00382830036863 | K890495 | 000 |
| 00382830036887 | K890495 | 000 |
| 00382830043588 | K890495 | 000 |
| 00382830043571 | K890495 | 000 |
| 00382830043465 | K890495 | 000 |
| 00382830041744 | K890495 | 000 |
| 00382830038188 | K890495 | 000 |
| 00382830037556 | K890495 | 000 |
| 00382830037532 | K890495 | 000 |
| 00382830037518 | K890495 | 000 |
| 00382830031592 | K890495 | 000 |