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Found 2 results

510(k) Data Aggregation

K Number

Device Name

AUDIOSCREENER OAE + ABR

Manufacturer

Date Cleared

2000-06-02

(60 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

KEDLY, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

AUDIOSCREENER OAE

Manufacturer

Date Cleared

2000-02-11

(22 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

KEDLY, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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