Who else makes this device?

Name: N4.5C Tips PK100
Brand: N4.5C Tips PK100

Ear Nose & Throat › DiagnosticAudiometer

N4.5C Tips PK100

Probe Ear Tip, neonate, N4.5C, Yellow (pack of 100). For DPOAE and TEOAE testing. Appropriate for newborns with approx. 4.5mm (0.18") ear canal. The N4.5C probe tip is to be used with…

Registry build 21.09.26

Probe Ear Tip, neonate, N4.5C, Yellow (pack of 100). For DPOAE and TEOAE testing. Appropriate for newborns with approx. 4.5mm (0.18″) ear canal. The N4.5C probe tip is to be used with X-series probes (via Neonate Tip Holder). NB: Otodynamics probe tips are latex-free. Recommended for single use.

2manufacturers in China registered for this device type

1catalogue number

8510(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 N4.5C Tips PK100
Listed by	Otodynamics, Ltd., United Kingdom
FDA product code	EWO
Device type	Audiometer
Device class	Class 2
Regulation	21 CFR 874.1050
Establishment	Manufacturer
Record published	2023-04-01

Specifications

Specifications
MRI safety	MR Unsafe
Single use	Yes
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for N4.5C Tips PK100
Catalogue number	Size	Status
T-N4.5C		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
K234095	2024-06-21
K240430	2024-03-15
K143395	2015-02-23
K072033	2007-11-13
K983350	1998-12-11
K983352	1998-12-11
K983351	1998-12-11
K962995	1997-01-10

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.