E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM— 510(k) K131131

Name: FDA 510(k) clearance K131131
Creator: U.S. Food and Drug Administration
Published: 2013-06-21

Substantially Equivalent

Intromedic Co., Ltd.

FDA 510(k) clearance K131131 for E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM, Substantially Equivalent on 2013-06-21. 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: 2013-04-22
Decision date: 2013-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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