Device Classification Name |
Oximeter
|
510(k) Number |
K100815 |
Device Name |
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 |
Applicant |
OXYPULSE |
ONE MACDONAL CENTER |
1 N. MACDONALD SUITE #8 |
MESA,
AZ
85201
|
|
Applicant Contact |
JAMES A DUNNING |
Correspondent |
OXYPULSE |
ONE MACDONAL CENTER |
1 N. MACDONALD SUITE #8 |
MESA,
AZ
85201
|
|
Correspondent Contact |
JAMES A DUNNING |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/23/2010 |
Decision Date | 06/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|