Cleared Traditional

BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER

K884033 · Biodynamics Corp. · Cardiovascular
Nov 1988
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K884033 is an FDA 510(k) clearance for the BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by Biodynamics Corp. (Bellevue, US). The FDA issued a Cleared decision on November 17, 1988, 55 days after receiving the submission on September 23, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K884033 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1988
Decision Date November 17, 1988
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DSB — Plethysmograph, Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770