| Device Classification Name |
Electrode, Ph, Stomach
|
| 510(k) Number |
K874710 |
| Device Name |
DIAMOND MEDICAL, INC. MODEL DM 600 |
| 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 | 11/12/1987 |
| Decision Date | 02/08/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|