510(k) K945359

AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H by Artema Medical AB — Product Code BYD

K945359 is an FDA 510(k) premarket notification submitted by Artema Medical AB for the device "AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H". The FDA issued a decision of Substantially Equivalent on February 21, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Artema Medical AB has at least 4 other 510(k) clearances on record.