Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AE-105D DIAGNOSTIC TYMPANOMETER

K-Number: K894260 · 1990-01-23

ApplicantAmerican Electromedics Corp.
Decision Date1990-01-23
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AE-105D DIAGNOSTIC TYMPANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is American Electromedics Corp.. It received FDA 510(k) clearance on 1990-01-23 under 510(k) number K894260. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AE-105D DIAGNOSTIC TYMPANOMETER?

AE-105D DIAGNOSTIC TYMPANOMETER is a medical device that received FDA 510(k) clearance on 1990-01-23. The listed applicant is American Electromedics Corp.. The 510(k) number is K894260.

When did AE-105D DIAGNOSTIC TYMPANOMETER receive FDA 510(k) clearance?

AE-105D DIAGNOSTIC TYMPANOMETER received FDA 510(k) clearance on 1990-01-23, under 510(k) number K894260.

Who is the listed applicant for AE-105D DIAGNOSTIC TYMPANOMETER?

The FDA 510(k) record lists American Electromedics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AE-105D DIAGNOSTIC TYMPANOMETER?

The FDA product code for AE-105D DIAGNOSTIC TYMPANOMETER is ETY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Electromedics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983051AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERK983049AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTERK983048AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTERK983046AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTERK972221K 15 AUDIOMETERK970279RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)

View all 20 devices →

Related Devices (Code: ETY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑