CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K122196
Device Name CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY
Applicant
BLACKROCK NEUROMED, LLC
117 west south street
oconomowoc, 
WI 
53066

Applicant Contact john ziobro
Correspondent
BLACKROCK NEUROMED, LLC
117 west south street
oconomowoc, 
WI 
53066

Correspodent Contact john ziobro
Regulation Number 882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWK   GWL   OLV  
Date Received 07/24/2012
Decision Date 05/02/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No