Device Classification Name |
Amplifier, Physiological Signal
|
510(k) Number |
K833413 |
Device Name |
COMPUTERSCOPE CPS-ABR |
Applicant |
RC ELECTRONICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
RC ELECTRONICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 882.1835
|
Classification Product Code |
|
Date Received | 09/30/1983 |
Decision Date | 11/28/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|