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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
Models GR101704, GR101704-RR
Device Name BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
Original Applicant
COVIDIEN
6135 gunbarrel ave.
boulder,  CO  80301
Original 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 (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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