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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K971616
Device Name BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)
Applicant
Data Sciences Intl., Inc.
4211 Lexington Ave., N.
Suite #2244
St. Paul,  MN  55126
Applicant Contact JIM HUHN
Correspondent
Data Sciences Intl., Inc.
4211 Lexington Ave., N.
Suite #2244
St. Paul,  MN  55126
Correspondent Contact JIM HUHN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/02/1997
Decision Date 11/04/1998
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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