Carnation Ambulatory Monitor

Recorder, Magnetic Tape, Medical

Bardy Diagnostics, Inc

The following data is part of a premarket notification filed by Bardy Diagnostics, Inc with the FDA for Carnation Ambulatory Monitor.

Pre-market Notification Details

Device IDK200870
510k NumberK200870
Device Name:Carnation Ambulatory Monitor
ClassificationRecorder, Magnetic Tape, Medical
Applicant Bardy Diagnostics, Inc 316 Occidental Avenue South, Suite B310 Seattle,  WA  98104
ContactJocelyn Kersten
CorrespondentJocelyn Kersten
Bardy Diagnostics, Inc 316 Occidental Avenue South, Suite B310 Seattle,  WA  98104
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-01
Decision Date2020-05-01

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