Device Classification Name |
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
|
510(k) Number |
K854357 |
Device Name |
GEM-6, WITH COMPONENTS |
Applicant |
DIAMOND ELECTRO-TECH, INC. |
1230 EISENHOWER PLACE |
ANN ARBOR,
MI
48104
|
|
Applicant Contact |
STEVEN ENZER |
Correspondent |
DIAMOND ELECTRO-TECH, INC. |
1230 EISENHOWER PLACE |
ANN ARBOR,
MI
48104
|
|
Correspondent Contact |
STEVEN ENZER |
Regulation Number | 870.4330 |
Classification Product Code |
|
Date Received | 10/29/1985 |
Decision Date | 01/08/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|