510(k) K081035

AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 by Osypka Medical, Inc. — Product Code DSB

K081035 is an FDA 510(k) premarket notification submitted by Osypka Medical, Inc. for the device "AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2". The FDA issued a decision of Substantially Equivalent on May 30, 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.