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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K770949
Device Name COMPUTER ECG TELE. TRANSMISSION TERMINAL
Applicant
The Okun Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Okun Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/25/1977
Decision Date 06/02/1977
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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