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FDA 510(k) Application Details - K982441
Device Classification Name
Audiometer
More FDA Info for this Device
510(K) Number
K982441
Device Name
Audiometer
Applicant
BENSON MEDICAL INSTRUMENTS CO.
2344 NICOLLET AVE. SOUTH, #150
MINNEAPOLIS, MN 55404 US
Other 510(k) Applications for this Company
Contact
DAVID P MAYOU
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
07/14/1998
Decision Date
10/09/1998
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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