510(k) K250882

SANSA HSAT by Huxley Medical — Product Code MNR

K250882 is an FDA 510(k) premarket notification submitted by Huxley Medical for the device "SANSA HSAT". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Huxley Medical has at least 3 other 510(k) clearances on record.