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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)

Manufacturer

AMERICAN ELECTROMEDICS CORP.

Date Cleared

1997-03-18

(54 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K983048,K983049,K983051

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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