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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 K962237
Device Name THUMPER CARDIOPULMONARY RESUSCITATOR
Applicant
Michigan Instruments, Inc.
4717 Talon Ct., SE
Grand Rapids,  MI  49512
Applicant Contact JAMES D MAATMAN
Correspondent
Michigan Instruments, Inc.
4717 Talon Ct., SE
Grand Rapids,  MI  49512
Correspondent Contact JAMES D MAATMAN
Regulation Number870.5200
Classification Product Code
DRM  
Date Received06/11/1996
Decision Date 09/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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