Cleared Traditional

BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER

K874361 · Biodynamics Corp. · Cardiovascular
Mar 1988
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K874361 is an FDA 510(k) clearance for the BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by Biodynamics Corp. (Seattle, US). The FDA issued a Cleared decision on March 16, 1988, 145 days after receiving the submission on October 23, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K874361 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1987
Decision Date March 16, 1988
Days to Decision 145 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