Device Classification Name |
Oximeter
|
510(k) Number |
K040214 |
Device Name |
MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
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 | 01/30/2004 |
Decision Date | 02/25/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|