FDA 510(k) Application Details - K955034

Device Classification Name	Device, Warning, Overload, External Limb, Powered   More FDA Info for this Device
510(K) Number	K955034
Device Name	Device, Warning, Overload, External Limb, Powered
Applicant	IMPACT MONITORS, INC. 1430 FLORIDA AVE,STE 218 LONGMONT, CO 80501 US Other 510(k) Applications for this Company
Contact	SUSAN JULIO Other 510(k) Applications for this Contact
Regulation Number	890.5575   More FDA Info for this Regulation Number
Classification Product Code	IRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/1995
Decision Date	04/10/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review