510(k) K961845

PERCUPUMP II WITH EDA by E-Z-Em, Inc. — Product Code DSB

K961845 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "PERCUPUMP II WITH EDA". The FDA issued a decision of Substantially Equivalent on January 23, 1997. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.