Device Classification Name |
Oximeter
|
510(k) Number |
K070732 |
Device Name |
BCI AUTOCON 3304 DIGITAL PULSE OXIMETER |
Applicant |
SMITHS MEDICAL PM, INC. |
N7 W22025 JOHNSON DR. |
WAUKESHA,
WI
53186 -1856
|
|
Applicant Contact |
DONALD ALEXANDER |
Correspondent |
SMITHS MEDICAL PM, INC. |
N7 W22025 JOHNSON DR. |
WAUKESHA,
WI
53186 -1856
|
|
Correspondent Contact |
DONALD ALEXANDER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/15/2007 |
Decision Date | 07/09/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|