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FDA 510(k) Application Details - K982249
Device Classification Name
Audiometer
More FDA Info for this Device
510(K) Number
K982249
Device Name
Audiometer
Applicant
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
4814 EAST SECOND ST.
BENICIA, CA 94510 US
Other 510(k) Applications for this Company
Contact
DONNA WARD
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
06/26/1998
Decision Date
08/07/1998
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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