510(k) K915226

ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT by Baxter Healthcare Corp — Product Code BZE

K915226 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT". The FDA issued a decision of Substantially Equivalent on Jan 12, 1993. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270. Baxter Healthcare Corp has 507 other 510(k) clearances on record.