510(k) K896365

BABYFLEX HEATED INFANT BREATHING CIRCUIT by Baxter Healthcare Corp — Product Code CAI

K896365 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BABYFLEX HEATED INFANT BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on Jan 22, 1990. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Baxter Healthcare Corp has 507 other 510(k) clearances on record.