510(k) K894911

SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 by Dantec Electronics, Inc. — Product Code GXZ

K894911 is an FDA 510(k) premarket notification submitted by Dantec Electronics, Inc. for the device "SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118". The FDA issued a decision of Substantially Equivalent on May 14, 1990. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Dantec Electronics, Inc. has at least 10 other 510(k) clearances on record.