510(k) K103704

REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP by Zephyr Sleep Technologies, Inc. — Product Code LRK

K103704 is an FDA 510(k) premarket notification submitted by Zephyr Sleep Technologies, Inc. for the device "REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP". The FDA issued a decision of Substantially Equivalent on March 23, 2012. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Zephyr Sleep Technologies, Inc. has at least 6 other 510(k) clearances on record.