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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K850021
Device Name ELECTROCARDIOGRAPH-ECG CALIPER
Applicant
Devcom, Inc.
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact LARRY R PILOT
Correspondent
Devcom, Inc.
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact LARRY R PILOT
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/03/1985
Decision Date 02/08/1985
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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