Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Zynex Monitoring System, Model CM-1600

K-Number: K223217 · 2023-06-16

ApplicantZynex Medical, Inc.
Decision Date2023-06-16
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zynex Monitoring System, Model CM-1600 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 2023-06-16 under 510(k) number K223217. 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 Zynex Monitoring System, Model CM-1600?

Zynex Monitoring System, Model CM-1600 is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Zynex Medical, Inc.. The 510(k) number is K223217.

When did Zynex Monitoring System, Model CM-1600 receive FDA 510(k) clearance?

Zynex Monitoring System, Model CM-1600 received FDA 510(k) clearance on 2023-06-16, under 510(k) number K223217.

Who is the listed applicant for Zynex Monitoring System, Model CM-1600?

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 Zynex Monitoring System, Model CM-1600?

The FDA product code for Zynex Monitoring System, Model CM-1600 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-WaveK191697Cardiac Monitor 1500

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 LimitedK211585Bodyport Cardiac ScaleBodyport, Inc.K203473SOZOImpediMed Limited

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.

↑