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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K892890
Device Name STETH-SHIELD(TM)
Applicant
North East Technology
P.O. Box 619
Geneva On The Lake,  OH  44041
Applicant Contact ASHE, R.N.
Correspondent
North East Technology
P.O. Box 619
Geneva On The Lake,  OH  44041
Correspondent Contact ASHE, R.N.
Regulation Number870.1875
Classification Product Code
DQD  
Date Received04/20/1989
Decision Date 12/01/1989
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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