Device Classification Name |
Amplitude-Integrated Electroencephalograph
|
510(k) Number |
K080217 |
Device Name |
COMPONENT NEUROMONITORING SYSTEM |
Applicant |
MOBERG RESEARCH, INC. |
224 S. MAPLE WAY |
AMBLER,
PA
19002
|
|
Applicant Contact |
Damon Lees |
Correspondent |
CITECH |
5200 BUTLER PIKE |
PLYMOUTH MEETING,
PA
19462 -1298
|
|
Correspondent Contact |
ROBERT MOSENKIS |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/29/2008 |
Decision Date | 11/05/2008 |
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
|
|
|