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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K893218
Device Name AP900/PRP MODULE AND ACCESSORIES, MODIFICATION
Applicant
Electromedics, Inc.
P.O. Box 3315
Englewood,  CO  80155
Applicant Contact DENNIS MCELWEE
Correspondent
Electromedics, Inc.
P.O. Box 3315
Englewood,  CO  80155
Correspondent Contact DENNIS MCELWEE
Regulation Number868.5830
Classification Product Code
CAC  
Date Received04/27/1989
Decision Date 06/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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