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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier And Signal Conditioner, Biopotential
510(k) Number K894161
Device Name ASC-950 ECG AMPLIFIER
Applicant
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Applicant Contact DONNA RAY
Correspondent
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Correspondent Contact DONNA RAY
Regulation Number870.2050
Classification Product Code
DRR  
Date Received06/14/1989
Decision Date 08/03/1989
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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