510(k) K953269

SAFECIRCUIT MANIFOLD/PULMONARY UNIT by Advanced Warming Systems, Inc. — Product Code CBN

K953269 is an FDA 510(k) premarket notification submitted by Advanced Warming Systems, Inc. for the device "SAFECIRCUIT MANIFOLD/PULMONARY UNIT". The FDA issued a decision of Substantially Equivalent on December 20, 1996. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Advanced Warming Systems, Inc. has at least 2 other 510(k) clearances on record.