COMPONENT NEUROMONITORING SYSTEM


Device Classification Name

amplitude-integrated electroencephalograph

510(k) Number K080217
Device Name COMPONENT NEUROMONITORING SYSTEM
Applicant
MOBERG RESEARCH, INC.
224 s. maple way
ambler, 
PA 
19002

Applicant Contact damon lees
Regulation Number 882.1400
Classification Product Code
OMA  
Subsequent Product Codes
GWQ   MHX   MUD   OLT   ORT  
Date Received 01/29/2008
Decision Date 11/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No