Claim: Mauna Kea Technologies was founded in 2000, and its Cellvizio pCLE system received U.S. Food and Drug Administration (a federal agency of the Department of Health and Human Services) clearance and CE mark in the European Union in 2005.
Evidence: 2000 2000 Founding of Mauna Kea Technologies 2005 Cellvizio pCLE system receives U.S. Food and Drug Administration (FDA) clearance and CE mark in the European Union The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services.