510(k) K161411

Care Cycle Connect Application by Respironics, Inc. — Product Code MOD

K161411 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "Care Cycle Connect Application". The FDA issued a decision of Substantially Equivalent on February 17, 2017. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Respironics, Inc. has at least 10 other 510(k) clearances on record.