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FDA 510(k)

Cardiac Monitor 1500

K-Number: K191697 · 2020-02-21

ApplicantZynex Medical, Inc.
Decision Date2020-02-21
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiac Monitor 1500 is the device name listed in this FDA 510(k) record. The listed applicant is Zynex Medical, Inc.. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K191697. 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 Cardiac Monitor 1500?

Cardiac Monitor 1500 is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Zynex Medical, Inc.. The 510(k) number is K191697.

When did Cardiac Monitor 1500 receive FDA 510(k) clearance?

Cardiac Monitor 1500 received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191697.

Who is the listed applicant for Cardiac Monitor 1500?

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

What is the FDA product code for Cardiac Monitor 1500?

The FDA product code for Cardiac Monitor 1500 is DSB.

Other records listing Zynex Medical, 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.

K233485M-WaveK223217Zynex Monitoring System, Model CM-1600

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, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.K211585Bodyport Cardiac ScaleBodyport, Inc.

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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