FDA.report

Audyx

Primary DI
07290017820019
Brand
Audyx
Company
AUDYX SYSTEMS LTD
Model
2.X
Catalog number
N/A
Device description
Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic sys
Published
2018-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EWOAudiometer

Product Code Classifications

CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290017820019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290017820019072900178200197290017820019

GMDN Terms

TermDefinition
Pure-tone audiometerAn electroacoustic device that generates tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presents them to a patient, typically one ear at a time with headphones, to evaluate hearing. The difference between the patient threshold and the normal (i.e., the hearing loss) is typically recorded on an audiogram chart in decibels. The device may be equipped with a bone vibrator for direct inner-ear stimulation to corroborate hearing loss. A masking tone system is necessary for testing if there is a large difference in hearing between the ears.

Sterilization Methods

Method

Contacts

PhoneEmail
+972186261199support@audyx.com

Regulatory Flags

DUNS number
600023242
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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