Device Classification Name |
oximeter
|
510(k) Number |
K150314 |
Device Name |
Masimo MightySat Rx Fingertip Pulse Oximeter |
Applicant |
MASIMO CORPORATION |
52 Discovery |
irvine,
CA
92618
|
|
Applicant Contact |
marguerite thomlinson |
Correspondent |
MASIMO CORPORATION |
52 Discovery |
irvine,
CA
92618
|
|
Correspondent Contact |
marguerite thomlinson |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 02/09/2015 |
Decision Date | 10/22/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|