aTymp

GUDID 04650075334003

The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders with the help of acoustic impedance tests, including tympanometry, Eustachian tube function (for intact and perforated tympanic membrane), acoustic reflex and acoustic reflex decay. The target population for aTymp system includes all ages. During the Eustachian tube function tests patient should be able to understand and perform instructions to do maneuvers.

NEUROSOFT, OOO

Otoacoustic emission system, battery-powered
Primary Device ID04650075334003
NIH Device Record Keya4179687-db01-4bcd-b408-070923d72639
Commercial Distribution StatusIn Commercial Distribution
Brand NameaTymp
Version Model NumberaTymp
Company DUNS643212926
Company NameNEUROSOFT, OOO
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104650075334003 [Primary]

FDA Product Code

PTPTympanometer, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-10
Device Publish Date2023-02-02

Devices Manufactured by NEUROSOFT, OOO

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04650075332078 - Steadys-Step2023-08-22 System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) da
04650075334003 - aTymp2023-02-10The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders with the help of acoustic impedance tests, including tympanometry, Eustachian tube function (for intact and perforated tympanic membrane), acoustic reflex and acoustic reflex decay. The target population for aTymp system includes all ages. During the Eustachian tube function tests patient should be able to understand and perform instructions to do maneuvers.
04650075334003 - aTymp2023-02-10 The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting

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