Device Classification Name |
Oximeter
|
510(k) Number |
K090662 |
Device Name |
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP |
Applicant |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Applicant Contact |
MARGUERITE THOMLINSON |
Correspondent |
MASIMO CORPORATION |
40 PARKER |
IRVINE,
CA
92618
|
|
Correspondent Contact |
MARGUERITE THOMLINSON |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/12/2009 |
Decision Date | 08/10/2009 |
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
|
|
|