CORTICAL MAPPING UNIT, MODEL CMU


Device Classification Name

electrode, cortical

510(k) Number K992194
Device Name CORTICAL MAPPING UNIT, MODEL CMU
Applicant
AD-TECH MEDICAL INSTRUMENT CORP.
1901 william st.
racine, 
WI 
53404 -1876

Applicant Contact john f ziobro
Correspondent
AD-TECH MEDICAL INSTRUMENT CORP.
1901 william st.
racine, 
WI 
53404 -1876

Correspodent Contact john f ziobro
Regulation Number 882.1310
Classification Product Code
GYC  
Date Received 06/29/1999
Decision Date 09/13/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No