Device Classification Name |
electrocardiograph
|
510(k) Number |
K953415 |
Device Name |
6200 VITAL SIGNS MONITOR |
Applicant |
BCI INTL., INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
DONAL ALEXANDER |
Correspondent |
BCI INTL., INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
DONAL ALEXANDER |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 07/20/1995 |
Decision Date | 10/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|