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FDA 510(k) Application Details - K962995
Device Classification Name
Audiometer
More FDA Info for this Device
510(K) Number
K962995
Device Name
Audiometer
Applicant
OTODYNAMICS, LTD.
36 BEACONSFIELD RD.,
HATFIELD HERTS AL10 8BB AL10 8BB GB
Other 510(k) Applications for this Company
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
08/01/1996
Decision Date
01/10/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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