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FDA 510(k)

Hyper Insight - ICH

K-Number: K240353 · 2024-07-01

ApplicantSk, Inc.
Decision Date2024-07-01
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hyper Insight - ICH is the device name listed in this FDA 510(k) record. The listed applicant is Sk, Inc.. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K240353. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hyper Insight - ICH?

Hyper Insight - ICH is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Sk, Inc.. The 510(k) number is K240353.

When did Hyper Insight - ICH receive FDA 510(k) clearance?

Hyper Insight - ICH received FDA 510(k) clearance on 2024-07-01, under 510(k) number K240353.

Who is the listed applicant for Hyper Insight - ICH?

The FDA 510(k) record lists Sk, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hyper Insight - ICH?

The FDA product code for Hyper Insight - ICH is QAS.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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