Device Classification Name |
Non-Normalizing Quantitative Electroencephalograph Software
|
510(k) Number |
K030489 |
Device Name |
BRM2 BRAIN MONITOR |
Applicant |
BRAINZ INSTRUMENTS LTD. |
25 CARBINE ROAD MT. WELLINGTON |
PO BOX 51-078, PARURANGA |
AUCKLAND,
NZ
|
|
Applicant Contact |
CHRIS MANDER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
CHARLES MACK |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/14/2003 |
Decision Date | 05/02/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|