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 ID: 04650075334003
• NIH Device Record Key: a4179687-db01-4bcd-b408-070923d72639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aTymp
• Version Model Number: aTymp
• Company DUNS: 643212926
• Company Name: NEUROSOFT, OOO
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04650075334003 [Primary]

FDA Product Code

• PTP: Tympanometer, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-10
• Device Publish Date: 2023-02-02

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• 04650075334003 - aTymp: 2023-02-10The 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 - aTymp: 2023-02-10 The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting