The following data is part of a premarket notification filed by Viasys Neurocare with the FDA for Nicoletone System V32 Amplifier.
| Device ID | K061908 |
| 510k Number | K061908 |
| Device Name: | NICOLETONE SYSTEM V32 AMPLIFIER |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | VIASYS NEUROCARE 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring VIASYS NEUROCARE 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-05 |
| Decision Date | 2006-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830037877 | K061908 | 000 |
| 00382830037822 | K061908 | 000 |
| 00382830037815 | K061908 | 000 |
| 00382830037655 | K061908 | 000 |
| 00382830037204 | K061908 | 000 |
| 00382830037167 | K061908 | 000 |
| 00382830037136 | K061908 | 000 |
| 00382830037112 | K061908 | 000 |
| 00382830036993 | K061908 | 000 |