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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K121806
Device Name BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
Applicant
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Applicant Contact ELIZABETH MALO
Correspondent
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Correspondent Contact ELIZABETH MALO
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
BZQ  
Date Received06/20/2012
Decision Date 09/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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