510(k) K861555

CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT by Respiratory Care, Inc. — Product Code BZD

K861555 is an FDA 510(k) premarket notification submitted by Respiratory Care, Inc. for the device "CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT". The FDA issued a decision of Substantially Equivalent on June 5, 1986. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.