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FDA 510(k) Application Details - K122496
Device Classification Name
Audiometer
More FDA Info for this Device
510(K) Number
K122496
Device Name
Audiometer
Applicant
BIO-LOGIC SYSTEMS CORP.
ONE BIOLOGIC PLAZA
MUNDELEIN, IL 60060 US
Other 510(k) Applications for this Company
Contact
TIMOTHY KARLOVSKY
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
08/16/2012
Decision Date
11/01/2012
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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