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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 K842705
Device Name MX2 ELECTRONIC STETHOSCOPE
Applicant
Medmax, Inc.
412 First St. Se
Washington,  DC  20003
Applicant Contact EVELYN HATTEN
Correspondent
Medmax, Inc.
412 First St. Se
Washington,  DC  20003
Correspondent Contact EVELYN HATTEN
Regulation Number870.1875
Classification Product Code
DQD  
Date Received07/11/1984
Decision Date 01/23/1985
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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