Device Classification Name |
Oximeter
|
510(k) Number |
K110028 |
Device Name |
MASIMO RADICAL Y PULSE CO-OXIMETER |
Applicant |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Applicant Contact |
SHELLY HARRIS |
Correspondent |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Correspondent Contact |
SHELLY HARRIS |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/05/2011 |
Decision Date | 03/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|