AUTOTRANSFUSION APPARATUS— 510(k) K873807

Name: FDA 510(k) clearance K873807
Creator: U.S. Food and Drug Administration
Published: 1988-03-09

Substantially Equivalent

Biodynamics Corp.

FDA 510(k) clearance K873807 for AUTOTRANSFUSION APPARATUS, Substantially Equivalent on 1988-03-09. Applicant: Biodynamics Corp.. Device class: 2.

Clearance details

Applicant: Biodynamics Corp.
Product code: Code CAC
Device class: Class 2
Regulation: 21 CFR 868.5830
Advisory panel: Anesthesiology
Date received: 1987-09-18
Decision date: 1988-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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K881968 — BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER1988-07-28
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Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.