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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K890142
Device Name A10 ULTRASCOPE RECORDER
Applicant
Ems Medical, Inc.
302 Lindbergh Ave.
Livermore,  CA  94550
Applicant Contact PAUL ULBRICH
Correspondent
Ems Medical, Inc.
302 Lindbergh Ave.
Livermore,  CA  94550
Correspondent Contact PAUL ULBRICH
Regulation Number870.2810
Classification Product Code
DSF  
Date Received01/13/1989
Decision Date 02/06/1989
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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