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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name audiometer
510(k) Number K922383
Device Name THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO
Applicant
MONITOR INSTRUMENTS, INC.
437 DIMMOCKS MILL RD.
HILLSBOROUGH,  NC  27278
Applicant Contact MACK J PRESLAR
Correspondent
MONITOR INSTRUMENTS, INC.
437 DIMMOCKS MILL RD.
HILLSBOROUGH,  NC  27278
Correspondent Contact MACK J PRESLAR
Regulation Number874.1050
Classification Product Code
EWO  
Date Received05/20/1992
Decision Date 01/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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