510(k) K062401

MODIFICATION TO LUCAS by Jolife AB — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2006
Date Received
August 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Cardiac, External
Device Class
Class II
Regulation Number
870.5200
Review Panel
CV
Submission Type