Device Classification Name |
Amplifier, Physiological Signal
|
510(k) Number |
K103140 |
Device Name |
NICOLET WIRELESS EEG |
Applicant |
CAREFUSION 209, INC. |
1850 Deming Way |
Middleton,
WI
53562
|
|
Applicant Contact |
ROBERT BURDGE |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 882.1835
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/25/2010 |
Decision Date | 04/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|