BRM2 BRAIN MONITOR


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
Regulation Number 882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
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