Device Classification Name |
Oximeter
|
510(k) Number |
K141518 |
FOIA Releasable 510(k) |
K141518
|
Device Name |
Nellcor Bedside Respiratory Patient Monitoring System |
Applicant |
COVIDIEN |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Applicant Contact |
JAMIE THOMAS |
Correspondent |
COVIDIEN |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
JAMIE THOMAS |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/2014 |
Decision Date | 03/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01804062 NCT01837537 NCT02075346
|
Reviewed by Third Party |
No
|
Combination Product |
No
|