483
Koios Medical, Inc.Koios Medical, Inc. – FDA 483, May 13, 2021
Record Details
Koios Medical, Inc., a medical software manufacturer in New York, NY, was issued a Form FDA-483 following an inspection. The inspection revealed two observations related to inadequate maintenance of device history records and a failure to maintain written Medical Device Reporting (MDR) procedures, including not registering for the eMDR system.
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ID · 527db7b3-8c0a-4505-9298-0d3f2d1cb700
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