510(k) K760891

INSPIRON I.M.V. SET UP by Inspiron Corp. — Product Code CBO

K760891 is an FDA 510(k) premarket notification submitted by Inspiron Corp. for the device "INSPIRON I.M.V. SET UP". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code CBO (Attachment, Intermittent Mandatory Ventilation (Imv)), a Class II device regulated under 21 CFR 868.5955. Inspiron Corp. has at least 10 other 510(k) clearances on record.