510(k) K081264

STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 by Children'S Health First, Inc. — Product Code FMQ

K081264 is an FDA 510(k) premarket notification submitted by Children'S Health First, Inc. for the device "STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002". The FDA issued a decision of Substantially Equivalent on February 13, 2009. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760.