CCA-100 (MODIFIED)

Audiometer

BENSON MEDICAL INSTRUMENTS CO.

The following data is part of a premarket notification filed by Benson Medical Instruments Co. with the FDA for Cca-100 (modified).

Pre-market Notification Details

Device IDK963681
510k NumberK963681
Device Name:CCA-100 (MODIFIED)
ClassificationAudiometer
Applicant BENSON MEDICAL INSTRUMENTS CO. 2344 NICOLLET AVE. SOUTH, #150 Minneapolis,  MN  55404
ContactDavid P Mayou
CorrespondentDavid P Mayou
BENSON MEDICAL INSTRUMENTS CO. 2344 NICOLLET AVE. SOUTH, #150 Minneapolis,  MN  55404
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-11
Decision Date1996-10-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.