510(k) K070985

AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC by Osypka Medical, Inc. — Product Code DSB

K070985 is an FDA 510(k) premarket notification submitted by Osypka Medical, Inc. for the device "AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC". The FDA issued a decision of Substantially Equivalent on February 1, 2008. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. Osypka Medical, Inc. has at least 6 other 510(k) clearances on record.