Device Classification Name |
Oximeter
|
510(k) Number |
K213676 |
Device Name |
Masimo Rad-G with Temperature |
Applicant |
Masimo Corporation |
52 Discovery |
Irvine,
CA
92618
|
|
Applicant Contact |
Sahar Bagheri |
Correspondent |
Masimo Corporation |
52 Discovery |
Irvine,
CA
92618
|
|
Correspondent Contact |
Sahar Bagheri |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/22/2021 |
Decision Date | 04/16/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|