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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K181912
Device Name Ascent Cardiorespiratory Diagnostic Software
Applicant
Medical Graphics Corporation
350 Oak Grove Pkwy.
St. Paul,  MN  55127 -8599
Applicant Contact Jim McGurran
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Code
BZC  
Date Received07/17/2018
Decision Date 04/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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