Home / 510(k) Clearances / K133301

510(k) K133301

ZOE FLUID STATUS MONITOR by Noninvasive Medical Technologies, Inc. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2014
Date Received
October 25, 2013
Clearance Type
Special
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 Noninvasive Medical Technologies, Inc.

  • K131509 — ZOE FLUID STATUS MONITOR (June 28, 2013)
  • K112830 — ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) (November 13, 2012)
  • K042113 — ZOE FLUID STATUS MONITOR (September 14, 2004)

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)
  • K191697 — Cardiac Monitor 1500 (February 21, 2020)
  • K180479 — ReDS System (February 28, 2019)