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FDA 510(k)

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER

K-Number: K881968 · 1988-07-28

ApplicantBiodynamics Corp.
Decision Date1988-07-28
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1988-07-28 under 510(k) number K881968. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER?

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER is a medical device that received FDA 510(k) clearance on 1988-07-28. The listed applicant is Biodynamics Corp.. The 510(k) number is K881968.

When did BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER receive FDA 510(k) clearance?

BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER received FDA 510(k) clearance on 1988-07-28, under 510(k) number K881968.

Who is the listed applicant for BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER?

The FDA 510(k) record lists Biodynamics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER?

The FDA product code for BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER is DSB.

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Other records listing Biodynamics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881631BIODYNAMICS AUTOTRANSFUSION RESERVOIRK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUSK874034ADR-22 AUTOMATIC DIALYZER REPROCESSOR

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Related Devices (Code: DSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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