E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM— 510(k) K111030

Name: FDA 510(k) clearance K111030
Creator: U.S. Food and Drug Administration
Published: 2011-10-21

Substantially Equivalent

Intromedic Co., Ltd.

FDA 510(k) clearance K111030 for E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM, Substantially Equivalent on 2011-10-21. Applicant: Intromedic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Intromedic Co., Ltd.
Product code: Code EOX
Device class: Class 2
Regulation: 21 CFR 874.4710
Advisory panel: Ear, Nose, Throat
Date received: 2011-04-13
Decision date: 2011-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guro-Gu , Seoul, KR

Download summary PDF View on FDA.gov ↗

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