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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 K894736
Device Name MT96000 PAPER CHART RECORDER
Applicant
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Applicant Contact DONNA J RAY
Correspondent
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Correspondent Contact DONNA J RAY
Regulation Number870.2810
Classification Product Code
DSF  
Date Received07/27/1989
Decision Date 12/13/1989
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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