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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Electrode, Surface, Electrocardiographic
510(k) Number K840358
Device Name IMPEDANCE/8200 MONITOR-MODEL 8300
Applicant
Aequitron Medical, Inc.
14130 23rd. Ave. North
Minneapolis,  MN  55441
Applicant Contact ROBERT C SAMEC
Correspondent
Aequitron Medical, Inc.
14130 23rd. Ave. North
Minneapolis,  MN  55441
Correspondent Contact ROBERT C SAMEC
Regulation Number870.2370
Classification Product Code
KRC  
Date Received01/26/1984
Decision Date 10/30/1984
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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