JLK-ICH— 510(k) K243363

Substantially Equivalent

JLK, Inc.

FDA 510(k) clearance K243363 for JLK-ICH, Substantially Equivalent on 2025-01-03. Applicant: JLK, Inc..

Clearance details

Applicant: JLK, Inc.
Product code: Code QAS
Advisory panel: Radiology
Date received: 2024-10-29
Decision date: 2025-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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