COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0


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

Correspodent Contact jean simon
Regulation Number 868.2375
Classification Product Code
BZQ  
Subsequent Product Codes
DQA   DSA  
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 NCT01294514NCT01306201
Reviewed by Third Party No

Combination Product

No