Device Classification Name |
oximeter
|
510(k) Number |
K031515 |
Device Name |
SPIROPRO SPO2 |
Applicant |
VIASYS HEALTHCARE GMBH |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887
|
|
Applicant Contact |
EARL DRAPER |
Correspondent |
VIASYS HEALTHCARE GMBH |
22705 SAVI RANCH PKWY. |
YORBA LINDA,
CA
92887
|
|
Correspondent Contact |
EARL DRAPER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/14/2003 |
Decision Date | 11/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|