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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K073079
Device Name THUMPER, MODEL: 1008
Applicant
Michigan Instruments, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOSTEIN
Correspondent
Michigan Instruments, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOSTEIN
Regulation Number870.5200
Classification Product Code
DRM  
Date Received10/31/2007
Decision Date 02/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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