MODEL I-2000 MONITOR


Device Classification Name

non-normalizing quantitative electroencephalograph software

510(k) Number K072382
Device Name MODEL I-2000 MONITOR
Applicant
INFINITE BIOMEDICAL TECHNOLOGIES
3600 clipper mill road
suite 410
baltimore, 
MD 
21211

Applicant Contact manan hathi
Correspondent
INFINITE BIOMEDICAL TECHNOLOGIES
3600 clipper mill road
suite 410
baltimore, 
MD 
21211

Correspodent Contact manan hathi
Regulation Number 882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
Date Received 08/24/2007
Decision Date 02/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No