Device Classification Name |
Oximeter
|
510(k) Number |
K000126 |
Device Name |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA |
Applicant |
MASIMO CORP. |
2852 KELVIN AVE. |
IRVINE,
CA
92614 -5826
|
|
Applicant Contact |
JAMES J CRONIN |
Correspondent |
MASIMO CORP. |
2852 KELVIN AVE. |
IRVINE,
CA
92614 -5826
|
|
Correspondent Contact |
JAMES J CRONIN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 01/18/2000 |
Decision Date | 04/14/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|