FDA 510(k) Application Details - K760859

Device Classification Name Audiometer

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510(K) Number K760859
Device Name Audiometer
Applicant TRACOR INSTRUMENTS, INC.

, US
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Regulation Number 874.1050

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Classification Product Code EWO
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Date Received 10/18/1976
Decision Date 10/29/1976
Decision SE - Substantially Equivalent
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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