Device Classification Name |
Oximeter
|
510(k) Number |
K945754 |
Device Name |
NEWOX2 |
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 | 870.2700
|
Classification Product Code |
|
Date Received | 11/23/1994 |
Decision Date | 07/17/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|