BreathePal Bilevel (GFM50-MD2201)

BreathePal Bilevel (GFM50-MD2201) is the device name listed in this FDA 510(k) record. The listed applicant is Compal Electronics, Inc.. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K252078. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.