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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 K881055
Device Name ECG MONITOR AND RESPIRATION PACER
Applicant
D. E. Hokanson, Inc.
2450 Newport Way SE
Issaquah,  WA  98027
Applicant Contact EUGENE HOKANSON
Correspondent
D. E. Hokanson, Inc.
2450 Newport Way SE
Issaquah,  WA  98027
Correspondent Contact EUGENE HOKANSON
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/08/1988
Decision Date 08/19/1988
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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