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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Phonocatheter, Intracavitary
510(k) Number K955887
Device Name NEWMED ABP-LITE
Applicant
Newmed Corp.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact DONALD R STONE
Correspondent
Newmed Corp.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact DONALD R STONE
Regulation Number870.1270
Classification Product Code
DXW  
Date Received12/28/1995
Decision Date 09/05/1996
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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