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FDA 510(k) Application Details - K143395
Device Classification Name
Audiometer
More FDA Info for this Device
510(K) Number
K143395
Device Name
Audiometer
Applicant
OTODYNAMICS, LTD.
30-38 BEACONSFIELD RD.
HATFIELD, HERTS AL10 8BB GB
Other 510(k) Applications for this Company
Contact
Julian Rutherford
Other 510(k) Applications for this Contact
Regulation Number
874.1050
More FDA Info for this Regulation Number
Classification Product Code
EWO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/26/2014
Decision Date
02/23/2015
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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