510(k) K964401

KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) by Ludlow Technical Products — Product Code FMT

K964401 is an FDA 510(k) premarket notification submitted by Ludlow Technical Products for the device "KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)". The FDA issued a decision of Substantially Equivalent on February 6, 1997. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Ludlow Technical Products has at least 4 other 510(k) clearances on record.