FDA Registration
Active
🇩🇪 Germany
PATH
Reg #: 3008111228
·
FEI: 3008111228
·
Expires 2026
Products
6
Proprietary Names
33
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- PATH
- Registration Number
- 3008111228
- FEI Number
- 3008111228
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Landsberger Strasse 65
- City
- Germering Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K220139
Owner / Operator
- Firm Name
- PATH
- Operator Number
- 10042983
- Address
- Landsberger Strasse 65
- City
- Germering
- State
- Bavaria
- Postal Code
- 82110
- Country
- DE
- Correspondent
- Johann Oswald
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2013-01-17 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2022-08-04 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2019-02-18 |
| Tympanometer, Exempt | PTP | Class 2 | Ear, Nose, Throat | No | 2020-01-10 |
| Cushion, Earphone (For Audiometric Testing) | ETT | Class 1 | Ear, Nose, Throat | No | 2019-02-21 |
| Tester, Auditory Impedance | ETY | Class 2 | Ear, Nose, Throat | No | 2014-12-03 |
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
AuDX PRO - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06)
AuDX - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06)
Sentiero - DD45/contra,HDA280,HDA300,B71,B81,PIEP/Mono(w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB04,AB05,AB06)
AuDX PRO FLEX - DD45/contra,HDA280,HDA300,B71,B81,PIEP/Mono(w.FoamTips),,AB01,AB04,AB03,AB05,AB06)
NavPRO ONE - DD45/contra, HDA 280, HDA 300, B71, B81, PIEP/Mono (w.FoamTips), PECC/-HP(w.Coupler),AB01,AB03,AB05,AB06)
TY-101 - DD45/contra,DD65/DD65V2,HDA300,B81,PIEP/Mono(w.FoamTips),AB01,AB04,AB03,AB05,AB06)
Algo7i
Establishment Types
Manufacture Medical Device