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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K182868
Device Name INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
Applicant
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Samir Ibrahim
Correspondent
Covidien, LLC
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Samir Ibrahim
Regulation Number870.2700
Classification Product Code
MUD  
Subsequent Product Code
QEM  
Date Received10/12/2018
Decision Date 01/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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