KIDNEY PERFUSION MACHINE— 510(k) K864140

Name: FDA 510(k) clearance K864140
Creator: U.S. Food and Drug Administration
Published: 1987-03-05

Substantially Equivalent

Advanced Equipment Development, Inc.

FDA 510(k) clearance K864140 for KIDNEY PERFUSION MACHINE, Substantially Equivalent on 1987-03-05. Applicant: Advanced Equipment Development, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Equipment Development, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 1986-10-21
Decision date: 1987-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grosse Pte Farms, MI, US

Download summary PDF View on FDA.gov ↗

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