Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K193626 |
Device Name |
Masimo Rad-97 Pulse CO-Oximeter and Accessories |
Applicant |
Masimo Corporation |
52 Discovery |
Irvine,
CA
92618
|
|
Applicant Contact |
Linus Park |
Correspondent |
Masimo Corporation |
52 Discovery |
Irvine,
CA
92618
|
|
Correspondent Contact |
Linus Park |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/26/2019 |
Decision Date | 08/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|