510(k) K895881

MOTIONSPECT by Baltimore Therapeutic Equipment Co. — Product Code LXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1990
Date Received
October 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Column, Adsorption, Low Density, Lipoprotein
Device Class
Class III
Regulation Number
Review Panel
GU
Submission Type