AMPLAID A756 SCREENING ADMITTANCE METER

Tester, Auditory Impedance

AMPLAID

The following data is part of a premarket notification filed by Amplaid with the FDA for Amplaid A756 Screening Admittance Meter.

Pre-market Notification Details

Device IDK031978
510k NumberK031978
Device Name:AMPLAID A756 SCREENING ADMITTANCE METER
ClassificationTester, Auditory Impedance
Applicant AMPLAID PO BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
AMPLAID PO BOX 7007 Deerfield,  IL  60015
Product CodeETY  
CFR Regulation Number874.1090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-26
Decision Date2003-07-21
Summary:summary

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