510(k) K860124

HORIZON 2000 TRANSCUTANEOUS GAS MONITORING by Mennen Medical, Inc. — Product Code KLK

K860124 is an FDA 510(k) premarket notification submitted by Mennen Medical, Inc. for the device "HORIZON 2000 TRANSCUTANEOUS GAS MONITORING". The FDA issued a decision of Substantially Equivalent on May 9, 1986. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Mennen Medical, Inc. has at least 10 other 510(k) clearances on record.