Device Classification Name |
oximeter
|
510(k) Number |
K042536 |
Device Name |
MASIMO SET RAD 57 PULSE CO-OXIMETER |
Applicant |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Applicant Contact |
JAMES J CRONIN |
Correspondent |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Correspondent Contact |
JAMES J CRONIN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/20/2004 |
Decision Date | 01/19/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|