WAVEGUARD (TM) EEG CAP


Device Classification Name

electrode, cutaneous

510(k) Number K110223
Device Name WAVEGUARD (TM) EEG CAP
Applicant
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
8870 ravello ct
naples, 
FL 
34114

Applicant Contact daniel kamm
Correspondent
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
8870 ravello ct
naples, 
FL 
34114

Correspodent Contact daniel kamm
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 01/25/2011
Decision Date 06/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No