FDA 510(k)

Bodyport Cardiac Scale

K-Number: K211585 · 2022-07-29

Decision Date2022-07-29

Product CodeDSB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Bodyport Cardiac Scale is the device name listed in this FDA 510(k) record. The listed applicant is Bodyport, Inc.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K211585. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bodyport Cardiac Scale?

Bodyport Cardiac Scale is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Bodyport, Inc.. The 510(k) number is K211585.

When did Bodyport Cardiac Scale receive FDA 510(k) clearance?

Bodyport Cardiac Scale received FDA 510(k) clearance on 2022-07-29, under 510(k) number K211585.

Who is the listed applicant for Bodyport Cardiac Scale?

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

What is the FDA product code for Bodyport Cardiac Scale?

The FDA product code for Bodyport Cardiac Scale is DSB.

Related Devices (Code: DSB)

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.

K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC K243727Re:BalansMode Sensors AS K250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed Limited K223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.K203473SOZOImpediMed Limited

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.