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FDA 510(k) Application Details - K983049
Device Classification Name
Tester, Auditory Impedance
More FDA Info for this Device
510(K) Number
K983049
Device Name
Tester, Auditory Impedance
Applicant
AMERICAN ELECTROMEDICS CORP.
P.O. BOX 9169
CHICO, CA 95927 US
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Contact
FRANK FERGUSON
Other 510(k) Applications for this Contact
Regulation Number
874.1090
More FDA Info for this Regulation Number
Classification Product Code
ETY
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More FDA Info for this Product Code
Date Received
09/01/1998
Decision Date
11/18/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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