Carnation Ambulatory Monitor (CAM)

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 (cam).

Pre-market Notification Details

Device IDK210036
510k NumberK210036
Device Name:Carnation Ambulatory Monitor (CAM)
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 Received2021-01-06
Decision Date2021-02-05

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