Device Classification Name |
Oximeter
|
510(k) Number |
K133064 |
Device Name |
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 |
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 | 09/27/2013 |
Decision Date | 05/02/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|