LKC’s products are held to the highest standards of quality and compliance in the design, development, and manufacturing of equipment.
LKC Technologies is an ISO 13485:2003 & 2012 certified, FDA-registered medical device establishment with FDA 510(k) clearance on its products. LKC also has products installed worldwide with country specific medical device approvals where required. LKC’s devices are CE marked and FDA cleared. All LKC Electrophysiology Systems are RoHS compliant.
CE Certificate (pdf)