Vivosonic Inc

Address:222-5535 EGLINTON AVENUE WEST,TORONTO Ontario,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Audiometer (EWO) (10) Stimulator, Auditory, Evoked Response (GWJ) (10)

Premarket Exempt

Clear

Integrity V500 - 00627908010018 Catalog Number :

Device Description : Main handheld VivoLink unit for use with the first generation Integrity V500 sys Main handheld VivoLink unit for use with the first generation Integrity V500 system.The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)The following are accessories that can be used with the first generation Integrity V500 system: A61 Amplitrode: DI 00627908010025B71-10 Bone Conductor: DI 00627908010032ER-3A-ABR Insert Earphones: DI 00627908010049HDA 300 EP Headphones: DI 00627908010056P40-GP OAE Probe: DI 00627908010063P40-UG OAE Probe: DI 00627908010070

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity Amplitrode - 00627908010025 Catalog Number :

Device Description : One channel Amplitrode for use as an accessory with the first generation Integri One channel Amplitrode for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity Bone Conductor - 00627908010032 Catalog Number :

Device Description : Bone conductor for use as an accessory with the first generation Integrity V500 Bone conductor for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018).The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity Insert Earphones - 00627908010049 Catalog Number :

Device Description : ER-3A insert earphones for use as an accessory with the first generation Integri ER-3A insert earphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity EP Headphones - 00627908010056 Catalog Number :

Device Description : HDA-300 EP headphones for use as an accessory with the first generation Integrit HDA-300 EP headphones for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity OAE Probe - 00627908010063 Catalog Number :

Device Description : GP OAE probe for use as an accessory with the first generation Integrity V500 sy GP OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity OAE Probe - 00627908010070 Catalog Number :

Device Description : UG OAE probe for use as an accessory with the first generation Integrity V500 sy UG OAE probe for use as an accessory with the first generation Integrity V500 system (DI: 00627908010018). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity V500 - 00627908020017 Catalog Number :

Device Description : Main handheld VivoLink unit for use with second generation Integrity V500 system Main handheld VivoLink unit for use with second generation Integrity V500 system.The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)The following are accessories that may be used with the second generation Integrity V500 system: A81 Amplitrode: DI 00627908020024A82 Amplitrode: DI 00627908020031A90 VivoAmp: DI 00627908020048B71W Bone Conductor: DI 00627908020055ER-2-800 Insert Earphones: DI 00627908020062ER-3A-800 Insert Earphones: DI 00627908020079ER-3C-800 Insert Earphones: DI 00627908020086H-800 EP Headphones: DI 00627908020093H-801 EP Headphones: DI 00627908020109P81-GP OAE Probe: DI 00627908020116P81-UG OAE Probe: DI 00627908020123Computer: DI 00627908020130

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity Amplitrode - 00627908020024 Catalog Number :

Device Description : One channel Amplitrode for use as an accessory with the second generation of the One channel Amplitrode for use as an accessory with the second generation of the Integrity V500 system (DI: 00627908020017).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

Integrity Amplitrode - 00627908020031 Catalog Number :

Device Description : Dual channel Amplitrode for use as an accessory with the second generation Integ Dual channel Amplitrode for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017).The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)

Device Class : 2

Duns Number: 201740425

Premarket Exempt : No

Product Code : EWO, GWJ

Prescription Use : No

Device Count : 1

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