510(k) K900104

TCPM II TOURNIQUET CUFF PRESSURE MONITOR by Electromedics, Inc. — Product Code KCY

K900104 is an FDA 510(k) premarket notification submitted by Electromedics, Inc. for the device "TCPM II TOURNIQUET CUFF PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on March 15, 1990. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Electromedics, Inc. has at least 10 other 510(k) clearances on record.