I RUNE (I-200L)— 510(k) K122410

Substantially Equivalent

Medirune Co, Ltd.

FDA 510(k) clearance K122410 for I RUNE (I-200L), Substantially Equivalent on 2013-11-12. Applicant: Medirune Co, Ltd..

Clearance details

Applicant: Medirune Co, Ltd.
Product code: Code NUH
Advisory panel: Neurology
Date received: 2012-08-08
Decision date: 2013-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangnam-Gu, KR

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