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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 K951124
Device Name CAD-2000 CARDIAC ASSIST DEVICE
Applicant
Eee Medical Ent.
3817 SW 15th St.
Gainesville,  FL  32608
Applicant Contact RANDALL L EVERETT
Correspondent
Eee Medical Ent.
3817 SW 15th St.
Gainesville,  FL  32608
Correspondent Contact RANDALL L EVERETT
Regulation Number870.5200
Classification Product Code
DRM  
Date Received02/24/1995
Decision Date 11/20/1995
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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