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FDA 510(k) Application Details - K981142
Device Classification Name
Audiometer
More FDA Info for this Device
510(K) Number
K981142
Device Name
Audiometer
Applicant
BERNAFON-MAICO, INC.
9675 WEST 76TH ST.
EDEN PRAIRIE, MN 55344 US
Other 510(k) Applications for this Company
Contact
SCOTT SAVRE
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
03/30/1998
Decision Date
04/22/1998
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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