Rubicon SA System

Ventilatory Effort Recorder

Dymedix Diagnostics, Inc.

The following data is part of a premarket notification filed by Dymedix Diagnostics, Inc. with the FDA for Rubicon Sa System.

Pre-market Notification Details

Device IDK200654
510k NumberK200654
Device Name:Rubicon SA System
ClassificationVentilatory Effort Recorder
Applicant Dymedix Diagnostics, Inc. 5985 Rice Creek Parkway Shoreview,  MN  55126
ContactJim Moore
CorrespondentPaul Dryden
Dymedix Diagnostics, Inc. C/o ProMedic, LLC 131 Bay Point Dr NE St. Petersburg,  FL  33704
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-12
Decision Date2020-07-22

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