Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K111933 |
Device Name |
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 |
Applicant |
COVIDIEN |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Applicant Contact |
Jean Simon |
Correspondent |
COVIDIEN |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
Jean Simon |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/08/2011 |
Decision Date | 03/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01294514 NCT01306201
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|