Device Classification Name |
Pulse Oximeter For Over-The-Counter Use
|
510(k) Number |
K211498 |
Device Name |
Nonin OTC Pulse Oximeter Model 3250 |
Applicant |
Nonin Medical Inc. |
13700 1st Avenue North |
Plymouth,
MN
55441
|
|
Applicant Contact |
Lisa Pray |
Correspondent |
Covance by Labcorp |
13700 1st Avenue North |
Plymouth,
MN
55441
|
|
Correspondent Contact |
Sheila Mena |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/14/2021 |
Decision Date | 11/13/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|