SHUNTCHECK – CSF SHUNT FLOW DETECTOR


Device Classification Name

shunt, central nervous system and components

510(k) Number K080168
Device Name SHUNTCHECK – CSF SHUNT FLOW DETECTOR
Applicant
NEURO DIAGNOSTIC DEVICES
one neshamaminy interplex
suite 300
trevose, 
PA 
19053

Applicant Contact frederick j fritz
Correspondent
NEURO DIAGNOSTIC DEVICES
one neshamaminy interplex
suite 300
trevose, 
PA 
19053

Correspodent Contact frederick j fritz
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 01/23/2008
Decision Date 05/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No