Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K023975 |
Device Name |
VOYAGER LINUX |
Applicant |
Z-KAT, INC. |
2903 SIMMS ST. |
HOLLYWOOD,
FL
33020
|
|
Applicant Contact |
CHRISTINA VANCE |
Correspondent |
Z-KAT, INC. |
2903 SIMMS ST. |
HOLLYWOOD,
FL
33020
|
|
Correspondent Contact |
CHRISTINA VANCE |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 12/02/2002 |
Decision Date | 12/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|