Who else makes this device?

Name: Otometrics
Brand: Otometrics

Ear Nose & Throat › DiagnosticAudiometer

Otometrics

1081 Madsen A450, ANSI Cal., Incl. HB-8 Headset and Insert Phone (US only)

Registry build 21.09.26

2manufacturers in China registered for this device type

3catalogue 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 Otometrics
Listed by	Natus Medical Denmark ApS, Denmark
FDA product code	EWO
Device type	Audiometer
Device class	Class 2
Regulation	21 CFR 874.1050
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2017-06-07
Record revised	2025-10-30 (version 8)

Specifications

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

Catalogue Numbers

Catalogue numbers for Otometrics
Catalogue number	Size	Status
Madsen A450		In distribution
Madsen A450		In distribution
Madsen A450		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.