JLK-SDH
K-Number: K243611 · 2025-03-03
ApplicantJLK, Inc.
Decision Date2025-03-03
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
JLK-SDH is a medical device manufactured by JLK, Inc.. It received FDA 510(k) clearance on 2025-03-03 under approval number K243611. 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 JLK-SDH?
JLK-SDH is a medical device that received FDA 510(k) clearance on 2025-03-03. It is manufactured by JLK, Inc.. The 510(k) number is K243611.
When was JLK-SDH approved by the FDA?
JLK-SDH received FDA 510(k) clearance on 2025-03-03, under approval number K243611.
What company makes JLK-SDH?
JLK-SDH is manufactured by JLK, Inc..
What is the FDA product code for JLK-SDH?
The FDA product code for JLK-SDH is QAS.
Other Devices by JLK, Inc.
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.