Device Classification Name |
Oximeter
|
510(k) Number |
K081659 |
Device Name |
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L |
Applicant |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Applicant Contact |
MARGUERITE THOMLINSON |
Correspondent |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Correspondent Contact |
MARGUERITE THOMLINSON |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/12/2008 |
Decision Date | 09/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|