Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K022100 |
Device Name |
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 |
Applicant |
IMAGE-GUIDED NEUROLOGICS, INC. |
2290 W. EAU GALLIE BLVD. |
SUITE 210 |
MELBOURNE,
FL
32935
|
|
Applicant Contact |
DAVID M LEE |
Correspondent |
IMAGE-GUIDED NEUROLOGICS, INC. |
2290 W. EAU GALLIE BLVD. |
SUITE 210 |
MELBOURNE,
FL
32935
|
|
Correspondent Contact |
DAVID M LEE |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 06/28/2002 |
Decision Date | 09/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|