510(k) K221653

InfaTherm Disposable Infant Warming Mattress by International Biomedical — Product Code IMD

K221653 is an FDA 510(k) premarket notification submitted by International Biomedical for the device "InfaTherm Disposable Infant Warming Mattress". The FDA issued a decision of Substantially Equivalent on October 6, 2022. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. International Biomedical has at least 10 other 510(k) clearances on record.