510(k) K231313

Therapy Mask 3100 NC/SP by Respironics, Inc. — Product Code BZD

K231313 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "Therapy Mask 3100 NC/SP". The FDA issued a decision of Substantially Equivalent on July 28, 2023. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Respironics, Inc. has at least 10 other 510(k) clearances on record.