510(k) K972139

ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP by Davis & Geck, Inc. — Product Code BTM

K972139 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP". The FDA issued a decision of Substantially Equivalent on September 3, 1997. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.