510(k) K903731

SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME by Teca, Inc. — Product Code GWF

K903731 is an FDA 510(k) premarket notification submitted by Teca, Inc. for the device "SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME". The FDA issued a decision of Substantially Equivalent on February 4, 1991. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Teca, Inc. has at least 10 other 510(k) clearances on record.