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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number868.2375
Classification Product Code
BZQ  
Subsequent Product Codes
DQA   DSA  
Date Received07/08/2011
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
Predetermined Change
Control Plan Authorized		 No
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