Device Classification Name |
neurological stereotaxic instrument
|
510(k) Number |
K946252 |
Device Name |
STEREOPLAN |
Applicant |
RADIONICS SOFTWARE APPLICATIONS, INC. |
P.O. BOX 358 |
22 TERRY AVENUE |
BURLINGTON,
MA
01803 -0658
|
|
Applicant Contact |
LINDA JALBERT |
Correspondent |
RADIONICS SOFTWARE APPLICATIONS, INC. |
P.O. BOX 358 |
22 TERRY AVENUE |
BURLINGTON,
MA
01803 -0658
|
|
Correspondent Contact |
LINDA JALBERT |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 12/23/1994 |
Decision Date | 03/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|