Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008111228

FEI Number

3008111228

Entity Name

PATH

City/State/Country

Germering Bavaria, DE

Establishment Address

Landsberger Strasse 65, Germering Bavaria 82110, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PATH (Owner Number: 10042983)

Owner / Operator Contact Address

Landsberger Strasse 65, Germering, DE-BY 82110, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100661

PMA Number

N/A

All Registered Proprietary Names

SENTI NANOAUDIO QSCREEN ELECTRODE TRUNK CABLE 1077, ABR ELECTRODE CABLE ELECTRODE CABLE Probe EP-TY Probe EP-DP VIP Probe EP-DP Probe EP-LT NANOTYMP Ear tip soft tip 9mm EARTIP,6-10MM,PROBE A EARTIP,4.6-7MM,PROBE A 1077 EARTIP 12-16 BLUE 1077 EARTIP 5MM BLUE 1077 EARTIP 9-13 FOAM Eartip, Soft Tip 14 mm Eartip, Soft Tip 10 mm EARTIP,4.5MM,PROBE S 1077 EARTIP 8-11 TRANS 50 PCS EARTIP,18MM,PROBE A 1077, DPOAE/TEOAE PROBE 1077 PROBE TIP 10 PCS 1077, ALPHA DPOAE PROBE 1077, TEOAE PROBE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2013-01-17
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2022-08-04
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2019-02-18
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2019-02-21
PTP	Tympanometer, Exempt	Ear, Nose, Throat	Class 2	874.1090	2020-01-10
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	Class 1	874.1100	2019-02-21
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2019-02-21

Official Correspondent

Johann Oswald

US Agent Details

Christopher Previte Email: chrisprevite@atlanticbb.net Phone: (814) 2427949

Related Public Records

Same Entity

PATH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

Registration Number	Establishment Name	Location
2011951	AMBCO ELECTRONICS, A CALIFORNIA CORP.	TUSTIN, CA, US
3013333417	HEAR.COM LLC (TELE-DX)	Coral Gables, FL, US
3013598036	WAHTS Hearing LLC	West Lebanon, NH, US
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3043496923	EARGYM LTD	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008111228. Last updated year: 2026. Please use registration number 3008111228 when referencing this establishment in official correspondence.