JLK-AILink
K-Number: K250348 · 2025-02-25
ApplicantJLK, Inc.
Decision Date2025-02-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
JLK-AILink is a medical device manufactured by JLK, Inc.. It received FDA 510(k) clearance on 2025-02-25 under approval number K250348. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the JLK-AILink?
JLK-AILink is a medical device that received FDA 510(k) clearance on 2025-02-25. It is manufactured by JLK, Inc.. The 510(k) number is K250348.
When was JLK-AILink approved by the FDA?
JLK-AILink received FDA 510(k) clearance on 2025-02-25, under approval number K250348.
What company makes JLK-AILink?
JLK-AILink is manufactured by JLK, Inc..
What is the FDA product code for JLK-AILink?
The FDA product code for JLK-AILink is LLZ.
Other Devices by JLK, Inc.
Related Devices (Code: LLZ)
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.