Cleared Traditional

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER

K881968 · Biodynamics Corp. · Cardiovascular
Jul 1988
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K881968 is an FDA 510(k) clearance for the BIODYNAMICS MODEL BI-400 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 July 28, 1988, 78 days after receiving the submission on May 11, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K881968 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1988
Decision Date July 28, 1988
Days to Decision 78 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