Piano

AUDIOMETER. Piano Plus VRA is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction,…

Registry build 21.09.26

AUDIOMETER. Piano Plus VRA is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; supra-threshold tests; High Frequency and Multi-frequency audiometry; Bekesy and MLD tests; pediatric audiometry. Piano Plus VRA with Printer has, in addition, an integrated thermal printer.

2manufacturers in China registered for this device type
6catalogue numbers in this listing

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 Piano
Listed by Inventis SRL, Italy
FDA product code EWO
Device type Audiometer
Device class Class 2
Regulation 21 CFR 874.1050
Establishment Manufacturer
Premarket notification Exempt
Record published 2016-09-17
Record revised 2023-08-03 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for Piano
Catalogue number Size Status
PIANO PLUS VRA WITH PRINTER In distribution
PIANO PLUS WITH PRINTER In distribution
PIANO BASIC In distribution
PIANO PLUS In distribution
PIANO PLUS VRA In distribution
PIANO BASIC WITH PRINTER 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

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