ADR-22 AUTOMATIC DIALYZER REPROCESSOR— 510(k) K874034

Name: FDA 510(k) clearance K874034
Creator: U.S. Food and Drug Administration
Published: 1987-10-23

Substantially Equivalent

Biodynamics Corp.

FDA 510(k) clearance K874034 for ADR-22 AUTOMATIC DIALYZER REPROCESSOR, Substantially Equivalent on 1987-10-23. Applicant: Biodynamics Corp.. Device class: 2.

Clearance details

Applicant: Biodynamics Corp.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1987-10-05
Decision date: 1987-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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