510(k) K111378

OXIMETRY INTERFACE KIT by Philips Respironics, Inc. — Product Code MNS

K111378 is an FDA 510(k) premarket notification submitted by Philips Respironics, Inc. for the device "OXIMETRY INTERFACE KIT". The FDA issued a decision of Substantially Equivalent on October 4, 2011. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Philips Respironics, Inc. has at least 1 other 510(k) clearance on record.