INSIGHT MILLENNIUM III


Device Classification Name

electromyograph, diagnostic

510(k) Number K023209
Device Name INSIGHT MILLENNIUM III
Original Applicant
FASSTECH
76 treble cove rd.
building #2
north billerica, 
MA 
01862

Original Contact lee brody
Regulation Number 890.1375
Classification Product Code
IKN  
Subsequent Product Code
HCC  
Date Received 09/26/2002
Decision Date 10/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No