510(k) K141384

WHISPERJECT AUTOINJECTOR by Scandinavian Health Limited — Product Code KZH

K141384 is an FDA 510(k) premarket notification submitted by Scandinavian Health Limited for the device "WHISPERJECT AUTOINJECTOR". The FDA issued a decision of Substantially Equivalent on September 12, 2014. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Scandinavian Health Limited has at least 2 other 510(k) clearances on record.