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
|
|
Correspondent Contact |
FREDERICK J FRITZ |
Regulation Number | 882.5550
|
Classification Product Code |
|
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
|
|
|