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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 K823281
Device Name MODEL RM 6000, 6100,6200 POLYGRAPH
Applicant
Nihon Kohden America, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Nihon Kohden America, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/03/1982
Decision Date 12/22/1982
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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