Home / 510(k) Clearances / K874361

510(k) K874361

BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER by Biodynamics Corp. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1988
Date Received
October 23, 1987
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 Biodynamics Corp.

  • K051675 — BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER (March 16, 2006)
  • K884033 — BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER (November 17, 1988)
  • K881631 — BIODYNAMICS AUTOTRANSFUSION RESERVOIR (September 9, 1988)
  • K881968 — BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER (July 28, 1988)
  • K873807 — AUTOTRANSFUSION APPARATUS (March 9, 1988)
  • K874034 — ADR-22 AUTOMATIC DIALYZER REPROCESSOR (October 23, 1987)
  • K870052 — INFUMIX MIXING CONTAINER (February 27, 1987)
  • K822715 — PLATELET CENTRIFUGE (September 30, 1982)
  • K822716 — UNIVERSAL CENTRIFUGE (September 30, 1982)
  • K822422 — BASIC CENTRIFUGE (September 2, 1982)

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)