The following data is part of a premarket notification filed by Carefusion 209, Inc. with the FDA for Nicolet Wireless Eeg.
| Device ID | K103140 |
| 510k Number | K103140 |
| Device Name: | NICOLET WIRELESS EEG |
| Classification | Amplifier, Physiological Signal |
| Applicant | CAREFUSION 209, INC. 1850 Deming Way Middleton, WI 53562 |
| Contact | Robert Burdge |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-10-25 |
| Decision Date | 2011-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830037013 | K103140 | 000 |
| 00382830037006 | K103140 | 000 |