MYOGUIDE SYSTEM MODEL 8008


Device Classification Name

stimulator, nerve, battery-powered

510(k) Number K111985
Device Name MYOGUIDE SYSTEM MODEL 8008
Applicant
INTRONIX TECHNOLOGIES CORP.
611 west 5th street
austin, 
TX 
78701

Applicant Contact richard vincins, cqa, rac (us,eu)
Correspondent
INTRONIX TECHNOLOGIES CORP.
611 west 5th street
austin, 
TX 
78701

Correspodent Contact richard vincins, cqa, rac (us,eu)
Regulation Number 868.2775
Classification Product Code
BXN  
Date Received 07/12/2011
Decision Date 12/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No