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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Impedance Measuring Device Utilizing Oscillation Techniques
510(k) Number K152585
Device Name Resmon PRO FULL
Applicant
Medical Graphics Corp.
350 Oak Grove Pkwy.
Saint Paul,  MN  55127
Applicant Contact JIM PURDIE
Correspondent
Medical Graphics Corp.
350 Oak Grove Pkwy.
Saint Paul,  MN  55127
Correspondent Contact PAUL DRYDEN
Regulation Number868.1840
Classification Product Code
PNV  
Date Received09/10/2015
Decision Date 06/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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