Device Classification Name |
oximeter
|
510(k) Number |
K212555 |
Device Name |
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC |
Applicant |
Covidien llc |
6135 Gunbarrel Avenue |
Boulder,
CO
80301
|
|
Applicant Contact |
Anushka Jayaraman |
Correspondent |
Covidien llc |
6135 Gunbarrel Avenue |
Boulder,
CO
80301
|
|
Correspondent Contact |
Greeshma Kayala |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 08/13/2021 |
Decision Date | 05/06/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04559763 NCT04811963
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|