510(k) K911665

ESCORT 300 SERIES by Medical Data Electronics — Product Code LDD

K911665 is an FDA 510(k) premarket notification submitted by Medical Data Electronics for the device "ESCORT 300 SERIES". The FDA issued a decision of Substantially Equivalent on August 29, 1991. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Medical Data Electronics has at least 10 other 510(k) clearances on record.