Device Classification Name |
Oximeter
|
510(k) Number |
K121912 |
Device Name |
E1 EAR SENSORS |
Applicant |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Applicant Contact |
DAVID COLLETTE |
Correspondent |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Correspondent Contact |
DAVID COLLETTE |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 07/02/2012 |
Decision Date | 07/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|