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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Synchronizer, Electrocardiograph, Nuclear
510(k) Number K780510
Device Name NUCLEAR STETHOSCOPE
Applicant
Bios, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bios, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1410
Classification Product Code
IYY  
Date Received03/30/1978
Decision Date 04/18/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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