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510(k) Data Aggregation

K Number

Device Name

Otowave 302 Portable Tympanometer

Manufacturer

Date Cleared

2017-07-28

(88 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

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N/A

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Device Name :

Otowave 302 Portable Tympanometer

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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