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510(k) K191697

Cardiac Monitor 1500 by Zynex Medical, Inc. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
June 25, 2019
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)
  • K223217 — Zynex Monitoring System, Model CM-1600 (June 16, 2023)
  • 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)
  • K223217 — Zynex Monitoring System, Model CM-1600 (June 16, 2023)
  • K211585 — Bodyport Cardiac Scale (July 29, 2022)
  • K203473 — SOZO (April 19, 2021)
  • K193410 — SOZO Body Fluid Analyzer (October 2, 2020)
  • K180479 — ReDS System (February 28, 2019)
  • K172431 — Cardiovascular Analzyer (March 14, 2018)