510(k) K781916

FLEXT-THERM by E-Z-Em, Inc. — Product Code KXZ

K781916 is an FDA 510(k) premarket notification submitted by E-Z-Em, Inc. for the device "FLEXT-THERM". The FDA issued a decision of Substantially Equivalent on February 2, 1979. The device falls under product code KXZ (System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)), a Class III device regulated under 21 CFR 884.2982. E-Z-Em, Inc. has at least 10 other 510(k) clearances on record.