Device Classification Name |
Pulse Oximeter For Over-The-Counter Use
|
510(k) Number |
K214115 |
FOIA Releasable 510(k) |
K214115
|
Device Name |
MightySat -OTC |
Applicant |
Masimo Corporation |
52 Discovery |
Irvine,
CA
92618
|
|
Applicant Contact |
Kertana Shankar |
Correspondent |
Masimo Corporation |
52 Discovery |
Irvine,
CA
92618
|
|
Correspondent Contact |
Kertana Shankar |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/30/2021 |
Decision Date | 01/31/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|