FDA.reportPublic FDA data

Integrity EP Headphones

Primary DI
00627908020093
Brand
Integrity EP Headphones
Company
Vivosonic Inc
Model
H-800
Device description
HDA-300 EP headphones for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EWOAudiometer
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043396000INTEGRITY, MODEL V500Vivosonic, Inc.2005-01-24GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627908020093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627908020093006279080200936279080200930627908020093

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
201740425
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627908020192Bone ConductorB812023-06-12
00627908020178EP HeadphonesH-8022023-06-08
00627908020185ECochG AdaptersE-1102023-06-08
00627908020154Integrity VivoStimST-8002020-05-04
00627908010018Integrity V500V5002016-09-23
00627908010025Integrity Amplitrode A61 2016-09-23
00627908010032Integrity Bone Conductor B71-102016-09-23
00627908010049Integrity Insert Earphones ER-3A-ABR2016-09-23
00627908010056Integrity EP Headphones HDA 300 2016-09-23
00627908010063Integrity OAE Probe P40-GP2016-09-23
00627908010070Integrity OAE Probe P40-UG2016-09-23
00627908020017Integrity V500 V5002016-09-23
00627908020024Integrity Amplitrode A81 2016-09-23
00627908020031Integrity Amplitrode A82 2016-09-23
00627908020048Integrity VivoAmpA902016-09-23
00627908020055Integrity Bone Conductor B71W2016-09-23
00627908020062Integrity Insert Earphones ER-2-8002016-09-23
00627908020079Integrity Insert Earphones ER-3A-8002016-09-23
00627908020086Integrity Insert Earphones ER-3C-8002016-09-23
00627908020109Integrity EP Headphones H-8012016-09-23

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