Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K990326 |
Device Name |
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII |
Applicant |
RADIONICS SOFTWARE APPLICATIONS, INC. |
22 TERRY AVE. |
BURLINGTON,
MA
01803 -0658
|
|
Applicant Contact |
KEVIN J O'CONNELL |
Correspondent |
RADIONICS SOFTWARE APPLICATIONS, INC. |
22 TERRY AVE. |
BURLINGTON,
MA
01803 -0658
|
|
Correspondent Contact |
KEVIN J O'CONNELL |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 02/02/1999 |
Decision Date | 03/04/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|