510(k) K073079

THUMPER, MODEL: 1008 by Michigan Instruments, Inc. — Product Code DRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2008
Date Received
October 31, 2007
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