I-SCOPE 200— 510(k) K062364

Substantially Equivalent

Dongjin Medical Co., Ltd.

FDA 510(k) clearance K062364 for I-SCOPE 200, Substantially Equivalent on 2006-12-06. Applicant: Dongjin Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dongjin Medical Co., Ltd.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2006-08-14
Decision date: 2006-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sungnam-Si, Kyunggi-Do, 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.