Hyper Insight - ICH— 510(k) K240353

Substantially Equivalent

Sk, Inc.

FDA 510(k) clearance K240353 for Hyper Insight - ICH, Substantially Equivalent on 2024-07-01. Applicant: Sk, Inc..

Clearance details

Applicant: Sk, Inc.
Product code: Code QAS
Advisory panel: Radiology
Date received: 2024-02-05
Decision date: 2024-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

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