Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Zynex Medical, Inc.. It received FDA 510(k) clearance on 2023-06-16 under approval 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. It is manufactured by Zynex Medical, Inc.. The 510(k) number is K223217.

When was Zynex Monitoring System, Model CM-1600 approved by the FDA?

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

What company makes Zynex Monitoring System, Model CM-1600?

Zynex Monitoring System, Model CM-1600 is manufactured by Zynex Medical, Inc..

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.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026)

Other Devices by Zynex Medical, Inc.

K191697Cardiac Monitor 1500 K233485M-Wave

Related Devices (Code: DSB)

K172507SOZOImpediMed Limited K172196ECOM™ Cardiac Output Monitoring SystemEcom Medical, Inc. K172431Cardiovascular AnalzyerPhysiowave, Inc. K180479ReDS SystemSensible Medical Innovations , Ltd. K193410SOZO Body Fluid AnalyzerImpediMed Limited K191697Cardiac Monitor 1500Zynex Medical, 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.

↑