FDA 510(k) Application Details - K992439

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K992439
Device Name	Device, Biofeedback
Applicant	MYOTRONICS-NOROMED, INC. 15425 53RD AVE. SOUTH TUKWILA, WA 98188 US Other 510(k) Applications for this Company
Contact	FRAY ADIB Other 510(k) Applications for this Contact
Regulation Number	882.5050   More FDA Info for this Regulation Number
Classification Product Code	HCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/1999
Decision Date	08/13/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review