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FDA 510(k)

Carnation Ambulatory Monitor (CAM)

K-Number: K210036 · 2021-02-05

ApplicantBardy Diagnostics, Inc.
Decision Date2021-02-05
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Carnation Ambulatory Monitor (CAM) is a medical device manufactured by Bardy Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-02-05 under approval number K210036. 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 (CAM)?

Carnation Ambulatory Monitor (CAM) is a medical device that received FDA 510(k) clearance on 2021-02-05. It is manufactured by Bardy Diagnostics, Inc.. The 510(k) number is K210036.

When was Carnation Ambulatory Monitor (CAM) approved by the FDA?

Carnation Ambulatory Monitor (CAM) received FDA 510(k) clearance on 2021-02-05, under approval number K210036.

What company makes Carnation Ambulatory Monitor (CAM)?

Carnation Ambulatory Monitor (CAM) is manufactured by Bardy Diagnostics, Inc..

What is the FDA product code for Carnation Ambulatory Monitor (CAM)?

The FDA product code for Carnation Ambulatory Monitor (CAM) is DSH.

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Other Devices by Bardy Diagnostics, Inc.

K192556Carnation Ambulatory Monitor K191471Carnation Ambulatory Monitor K191000Carnation Ambulatory Monitor K200870Carnation Ambulatory Monitor K233110Carnation Ambulatory Monitor

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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.

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