Device Classification Name |
Electrode, Ph, Stomach
|
510(k) Number |
K875369 |
Device Name |
MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT |
Applicant |
DIAMOND MEDICAL, INC. |
150 EATON ST. |
ST. PAUL,
MN
55107
|
|
Applicant Contact |
RENELLE L NEAL |
Correspondent |
DIAMOND MEDICAL, INC. |
150 EATON ST. |
ST. PAUL,
MN
55107
|
|
Correspondent Contact |
RENELLE L NEAL |
Regulation Number | 876.1400
|
Classification Product Code |
|
Date Received | 12/31/1987 |
Decision Date | 02/05/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|