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 |
|