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)Issued Jun 12, 2026Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations4
Issue DateJun 12, 2026
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Nihon Kohden Digital Health Solutions, LLC
Location
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)
FEI Number
N/A
Country
United States
Issue Date
June 12, 2026
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
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