product-claims
Every record this desk has filed under product-claims, newest first, each with the number of sources it can still show you.
An infant monitor can give you a number. That is not a promise to keep a baby safe.
FDA's October 9 order codifies the existing class II classification for infant pulse and oxygen monitors, with special controls. The controls include testing whether caregivers can interpret the output and act on it. Read alongside the agency's earlier warning on infant monitors, the distinction is plain: an authorized measurement is not authorization to claim prevention of sudden infant death. The useful question is what the device is allowed to tell you, and what it cannot promise.
Also filed undermedical-devicesfdainfant-monitorspublic-record
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