EOS BRAND DISPOSABLE PROCTOSCOPE— 510(k) K954614

Name: FDA 510(k) clearance K954614
Creator: U.S. Food and Drug Administration
Published: 1996-04-10

Substantially Equivalent

North Eos Industries, Inc.

FDA 510(k) clearance K954614 for EOS BRAND DISPOSABLE PROCTOSCOPE, Substantially Equivalent on 1996-04-10. Applicant: North Eos Industries, Inc.. Device class: 2.

Clearance details

Applicant: North Eos Industries, Inc.
Product code: Code GCP
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1995-10-05
Decision date: 1996-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung Hsien 423, TW

Download summary PDF View on FDA.gov ↗

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