510(k) K103140 ยท GWL Amplifier, Physiological Signal
NICOLET WIRELESS EEG
| Applicant | Carefusion 209, Inc., Middleton WI, US |
| Decision | Substantially Equivalent, Apr 8, 2011 |
| Received | Oct 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103140
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2013 | Natus Neurology Incorporated Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier.
Product Usage:
The Nicolet Wireless EEG Ampli Terminated |
GWL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.