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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K934644
Device Name K3 SYSTEM
Applicant
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Applicant Contact MICHAEL SULLIVAN
Correspondent
Astro-Med, Inc.
600 E. Greenwich Ave.
West Warwick,  RI  02893
Correspondent Contact MICHAEL SULLIVAN
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/29/1993
Decision Date 11/01/1994
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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