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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 the device name listed in this FDA 510(k) record. The listed applicant is Bardy Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) 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. The listed applicant is Bardy Diagnostics, Inc.. The 510(k) number is K210036.

When did Carnation Ambulatory Monitor (CAM) receive FDA 510(k) clearance?

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

Who is the listed applicant for Carnation Ambulatory Monitor (CAM)?

The FDA 510(k) record lists Bardy Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Bardy Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233110Carnation Ambulatory MonitorK200870Carnation Ambulatory MonitorK192556Carnation Ambulatory MonitorK191471Carnation Ambulatory MonitorK191000Carnation Ambulatory Monitor

Related Devices (Code: DSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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