ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER

Audiometer

GRASON-STADLER, INC.

The following data is part of a premarket notification filed by Grason-stadler, Inc. with the FDA for Ilo88 Otodynamic Analyzer Screening Audiometer.

Pre-market Notification Details

Device IDK890124
510k NumberK890124
Device Name:ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER
ClassificationAudiometer
Applicant GRASON-STADLER, INC. 537 GREAT RD., P.O. BOX 1400 Littleton,  MA  01460
ContactJanice E Painter
CorrespondentJanice E Painter
GRASON-STADLER, INC. 537 GREAT RD., P.O. BOX 1400 Littleton,  MA  01460
Product CodeEWO  
CFR Regulation Number874.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-11
Decision Date1989-07-14

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