Device Classification Name |
Oximeter
|
510(k) Number |
K182887 |
Device Name |
Masimo Rad-67 Pulse CO-Oximeter and Accessories |
Applicant |
Masimo Corporation |
52 Discovery |
Irvine,
CA
92618
|
|
Applicant Contact |
Sindura Penubarthi |
Correspondent |
Masimo Corporation |
52 Discovery |
Irvine,
CA
92618
|
|
Correspondent Contact |
Sindura Penubarthi |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 10/15/2018 |
Decision Date | 03/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|