510(k) K072201

COMPUMEDICS SOMTE PSG RECORDING SYSTEM by Compumedics Limited — Product Code MNR

K072201 is an FDA 510(k) premarket notification submitted by Compumedics Limited for the device "COMPUMEDICS SOMTE PSG RECORDING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 2008. 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.