FDA 510(k)

Carnation Ambulatory Monitor

K-Number: K200870 · 2020-05-01

Decision Date2020-05-01

Product CodeDSH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Carnation Ambulatory Monitor is a medical device manufactured by Bardy Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-05-01 under approval number K200870. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carnation Ambulatory Monitor?

Carnation Ambulatory Monitor is a medical device that received FDA 510(k) clearance on 2020-05-01. It is manufactured by Bardy Diagnostics, Inc.. The 510(k) number is K200870.

When was Carnation Ambulatory Monitor approved by the FDA?

Carnation Ambulatory Monitor received FDA 510(k) clearance on 2020-05-01, under approval number K200870.

What company makes Carnation Ambulatory Monitor?

Carnation Ambulatory Monitor is manufactured by Bardy Diagnostics, Inc..

What is the FDA product code for Carnation Ambulatory Monitor?

The FDA product code for Carnation Ambulatory Monitor is DSH.

Related Clinical Trials

NCT06898138 Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations NOT_YET_RECRUITING NCT07502599 Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE) NOT_YET_RECRUITING NCT07240831 Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM) RECRUITING NCT04024293 Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry RECRUITING NCT05193084 Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure COMPLETED

Other Devices by Bardy Diagnostics, Inc.

K192556Carnation Ambulatory Monitor K191471Carnation Ambulatory Monitor K191000Carnation Ambulatory Monitor K210036Carnation Ambulatory Monitor (CAM) K233110Carnation Ambulatory Monitor

Related Devices (Code: DSH)

K162571Bioflux SoftwareBiotricity, Inc. K160704myPatch-sDms-Service, LLC K171936Peerbridge Cor(TM) SystemPeerbridge Health, Inc. K162503Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc. K163535my Patch slDms-Service, LLC K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.