Home / 510(k) Clearances / K223217

510(k) K223217

Zynex Monitoring System, Model CM-1600 by Zynex Medical, Inc. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2023
Date Received
October 17, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

Other clearances by Zynex Medical, Inc.

  • K233485 — M-Wave (January 26, 2024)
  • K191697 — Cardiac Monitor 1500 (February 21, 2020)
  • K121820 — INWAVE (August 24, 2012)
  • K111279 — NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM (September 20, 2011)

Other clearances for product code DSB

  • K250634 — BCM2-Body Composition Monitor (November 24, 2025)
  • K243727 — Re:Balans (October 16, 2025)
  • K250922 — Edema Guard Monitor (EGM) CardioSet-001 (September 9, 2025)
  • K232089 — SOZO Pro (October 17, 2023)
  • K211585 — Bodyport Cardiac Scale (July 29, 2022)
  • K203473 — SOZO (April 19, 2021)
  • K193410 — SOZO Body Fluid Analyzer (October 2, 2020)
  • K191697 — Cardiac Monitor 1500 (February 21, 2020)
  • K180479 — ReDS System (February 28, 2019)
  • K172431 — Cardiovascular Analzyer (March 14, 2018)