Device Classification Name |
oximeter
|
510(k) Number |
K033998 |
FOIA Releasable 510(k) |
K033998
|
Device Name |
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V |
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 |
|
Subsequent Product Code |
|
Date Received | 12/24/2003 |
Decision Date | 03/19/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|