Device Classification Name |
oximeter
|
510(k) Number |
K162675 |
Device Name |
Masimo Rainbow SET Intellivue Module Pulse CO-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 | 09/26/2016 |
Decision Date | 12/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|