FDA 510(k)

Carnation Ambulatory Monitor

K-Number: K233110 · 2023-11-22

Decision Date2023-11-22

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 2023-11-22 under approval number K233110. 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 2023-11-22. It is manufactured by Bardy Diagnostics, Inc.. The 510(k) number is K233110.

When was Carnation Ambulatory Monitor approved by the FDA?

Carnation Ambulatory Monitor received FDA 510(k) clearance on 2023-11-22, under approval number K233110.

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.

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Other Devices by Bardy Diagnostics, Inc.

K192556Carnation Ambulatory Monitor K191471Carnation Ambulatory Monitor K191000Carnation Ambulatory Monitor K200870Carnation Ambulatory Monitor K210036Carnation Ambulatory Monitor (CAM)

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Official Source

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