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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K200654
Device Name Rubicon SA System
Applicant
Dymedix Diagnostics, Inc.
5985 Rice Creek Parkway
Shoreview,  MN  55126
Applicant Contact Jim Moore
Correspondent
Dymedix Diagnostics, Inc. c/o ProMedic, LLC
131 Bay Point Dr NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.2375
Classification Product Code
MNR  
Date Received03/12/2020
Decision Date 07/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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