CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT

Audiometer

ETYMOTIC RESEARCH

The following data is part of a premarket notification filed by Etymotic Research with the FDA for Cub Dis Otoacoustic Emissions Test Instrument.

Pre-market Notification Details

• Device ID: K930553
• 510k Number: K930553
• Device Name: CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
• Classification: Audiometer
• Applicant: ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007
• Contact: Mead C Killion
• Correspondent: Mead C Killion; ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007
• Product Code: EWO
• CFR Regulation Number: 874.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-02-03
• Decision Date: 1993-09-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05711117245097	K930553	000
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