AUDIOMETER DA 323

Audiometer

FUTUREMED DIV. OF FUTURE IMPEX CORP.

The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Audiometer Da 323.

Pre-market Notification Details

Device IDK933222
510k NumberK933222
Device Name:AUDIOMETER DA 323
ClassificationAudiometer
Applicant FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park,  NY  11729
ContactMichael Davidson
CorrespondentMichael Davidson
FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park,  NY  11729
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-01
Decision Date1993-11-01

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