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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 K010587
Device Name ACTIVEECG
Applicant
Active Corp.
15 Main St.
Castine,  ME  04421
Applicant Contact KAREN SIEGEL
Correspondent
Active Corp.
15 Main St.
Castine,  ME  04421
Correspondent Contact KAREN SIEGEL
Regulation Number870.2300
Classification Product Code
DRT  
Date Received02/27/2001
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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