510(k) K252338

MySleepDash by Somnetics International, Inc. (Dba Transcend Inc) — Product Code BZD

K252338 is an FDA 510(k) premarket notification submitted by Somnetics International, Inc. (Dba Transcend Inc) for the device "MySleepDash". The FDA issued a decision of Substantially Equivalent on April 17, 2026. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905.