510(k) K252383

Somfit D by Compumedics Limited — Product Code MNR

K252383 is an FDA 510(k) premarket notification submitted by Compumedics Limited for the device "Somfit D". The FDA issued a decision of Substantially Equivalent on August 28, 2025. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Compumedics Limited has at least 8 other 510(k) clearances on record.