510(k) K992439

NORODYN 8000 SEMG SYSTEM, ND-8000 by Myotronics-Noromed, Inc. — Product Code HCC

K992439 is an FDA 510(k) premarket notification submitted by Myotronics-Noromed, Inc. for the device "NORODYN 8000 SEMG SYSTEM, ND-8000". The FDA issued a decision of Substantially Equivalent on August 13, 1999. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Myotronics-Noromed, Inc. has at least 6 other 510(k) clearances on record.