510(k) K853487

PATIENT BREATHING CIRCUIT by Infrasonics Corp. — Product Code BZD

K853487 is an FDA 510(k) premarket notification submitted by Infrasonics Corp. for the device "PATIENT BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on September 6, 1985. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Infrasonics Corp. has at least 10 other 510(k) clearances on record.