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 a medical device manufactured by Sk, Inc.. It received FDA 510(k) clearance on 2024-07-01 under approval 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. It is manufactured by Sk, Inc.. The 510(k) number is K240353.
When was Hyper Insight - ICH approved by the FDA?
Hyper Insight - ICH received FDA 510(k) clearance on 2024-07-01, under approval number K240353.
What company makes Hyper Insight - ICH?
Hyper Insight - ICH is manufactured by Sk, Inc..
What is the FDA product code for Hyper Insight - ICH?
The FDA product code for Hyper Insight - ICH is QAS.
Related Devices (Code: QAS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.