Recipient Title President and Chief Executive Officer, Nihon Kohden Digital Health Solutions, LLC, 14 Bunsen Irvine , CA 92618 United States, (b)(6), (b)(7)(C)
Issue DateJune 12, 2026
FEI NumberN/A
Violations4
CountryUnited States
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Subject
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Nihon Kohden Digital Health Solutions, LLC FDA Warning Letter, June 12, 2026
