Ear Nose & Throat › DiagnosticAudiometer

Integrity V500

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)…

Registry build 21.09.26

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 00627908020024 A82 Amplitrode: DI 00627908020031 A90 VivoAmp: DI 00627908020048 B71W Bone Conductor: DI 00627908020055 ER-2-800 Insert Earphones: DI 00627908020062 ER-3A-800 Insert Earphones: DI 00627908020079 ER-3C-800 Insert Earphones: DI 00627908020086 H-800 EP Headphones: DI 00627908020093 H-801 EP Headphones: DI 00627908020109 P81-GP OAE Probe: DI 00627908020116 P81-UG OAE Probe: DI 00627908020123 Computer: DI 00627908020130

2manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

All of them in Zhejiang.

Chinese manufacturers registered for FDA product code EWO
Manufacturer City Province Registered as Device types
Fastsound Acoustic Technology (Hangzhou) Co., Ltd. Hangzhou Zhejiang Manufacturer 6
Zoomax Technology Co., Limited Hangzhou Zhejiang Contract manufacturer 5

Record

Regulatory record for Integrity V500
Listed by Vivosonic Inc., Canada
FDA product code EWO
Device type Audiometer
Device class Class 2
Regulation 21 CFR 874.1050
Establishment Manufacturer
510(k) K043396
Record published 2016-09-23
Record revised 2020-04-21 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Integrity V500
Catalogue number Size Status
V500 In distribution
V500 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RadioEar A/S Interacoustics A/S 131
GN Otometrics A/S Natus Medical Denmark ApS 88
Audiometer Etymotic Research, Inc. 73
Siemens WS Audiology USA, Inc. 57
Bio-logic Natus Medical Incorporated 33
Welch Allyn, Inc. Welch Allyn, Inc. 29
Real-EAR WS Audiology USA, Inc. 26
Sanibel Supply A/S Interacoustics A/S 18
Natus Natus Medical Incorporated 14
Grason-Stadler Diagnostic Group LLC 12
Interacoustics Interacoustics A/S 12
Oscilla Inmedico A/S 12

Showing 12 of 348. All products under Audiometer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K033108 2003-10-27
K003364 2001-07-18

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer