Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K982279 |
Device Name |
VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 |
Applicant |
BCI INTL., INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53188
|
|
Applicant Contact |
DONALD J ALEXANDER |
Correspondent |
BCI INTL., INC. |
W238 N1650 ROCKWOOD DR. |
WAUKESHA,
WI
53188
|
|
Correspondent Contact |
DONALD J ALEXANDER |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 06/30/1998 |
Decision Date | 09/25/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|