Device Classification Name |
Electrode, Ph, Stomach
|
510(k) Number |
K934434 |
Device Name |
CYBERRX MODEL 7200 |
Applicant |
CYBERMED CONTROL SYSTEMS, INC. |
12770 HIGH BLUFF DR. |
SUITE 180 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
MICHAEL S GOLDBERG |
Correspondent |
CYBERMED CONTROL SYSTEMS, INC. |
12770 HIGH BLUFF DR. |
SUITE 180 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
MICHAEL S GOLDBERG |
Regulation Number | 876.1400
|
Classification Product Code |
|
Date Received | 08/23/1993 |
Decision Date | 01/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|