510(k) K842497

SERVOMED OXYMONITO SMK 363 by Litton Datamedix — Product Code KLK

K842497 is an FDA 510(k) premarket notification submitted by Litton Datamedix for the device "SERVOMED OXYMONITO SMK 363". The FDA issued a decision of Substantially Equivalent on October 4, 1984. 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. Litton Datamedix has at least 4 other 510(k) clearances on record.