Device Classification Name |
oximeter
|
510(k) Number |
K090438 |
Device Name |
REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR |
Applicant |
ENVITEC-WISMAR GMBH |
S65 W35739 PIPER ROAD |
EAGLE,
WI
53119
|
|
Applicant Contact |
STEPHEN GORSKI |
Correspondent |
ENVITEC-WISMAR GMBH |
S65 W35739 PIPER ROAD |
EAGLE,
WI
53119
|
|
Correspondent Contact |
STEPHEN GORSKI |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/20/2009 |
Decision Date | 07/24/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|