Device Classification Name |
oximeter
|
510(k) Number |
K103584 |
Device Name |
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS |
Applicant |
SHENZHEN ENVISEN INDUSTRY CO. LIMITED |
S65 W35739 PIPER ROAD |
EAGLE,
WI
53119
|
|
Applicant Contact |
STEPHEN H GORSKI |
Correspondent |
SHENZHEN ENVISEN INDUSTRY CO. LIMITED |
S65 W35739 PIPER ROAD |
EAGLE,
WI
53119
|
|
Correspondent Contact |
STEPHEN H GORSKI |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/07/2010 |
Decision Date | 06/10/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|