FDA.reportPublic FDA data

Sentiero Desktop Diagnostic

Primary DI
04260223141539
Brand
Sentiero Desktop Diagnostic
Company
PATH medical GmbH
Model
100497-US7
Device description
Sentiero Desktop Diagnostic Set US7Diagnostic Tymp with Diagnostic OAEContent:1. Sentiero Desktop (Tymp Diagnostic) AN100434-DG2. USB data cable AN1004183. Probe EP-TY long AN100188-US4. Probe EP-DP VIP blue AN100539-US5. FW Reflex & Tymp class1 AN1005616. Software label printer AN1004147. DPOAE Software AN1001108. TEOAE Software AN1001099. DPHiRES Software AN10053710. FMDPOAE Software AN10053611. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN10011612. Accessory box for Tymp probe AN10058713. Accessory box AB08 AN100734-P14. Power supply Senti / Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally15. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS AN100525-USA/-UK/-EU/-AUS or AN101251-USA/-UK/-EU/-AUS optionally16. Test cavity tymp AN100549
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ETYTester, Auditory Impedance
EWOAudiometer
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2
EWOAudiometerEar, Nose, Throat2
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133012000SENTIEROPath Medical GmbH2014-06-09EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260223141539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260223141539042602231415394260223141539

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551540334
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260223147760PATH ABR Electrodes1015072026-08-25
04260223148057Ear Coupler (Transparent) Set101506-52026-08-19
04260223147753Ear Coupler TR 30 pairs101506-302026-07-29
04260223145995Ear Coupler Set100890-302026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)100905-P-202026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)100906-P-202026-07-24
04260223147654Bone Conductor BC-2LD1014752026-07-24
04260223147661Bone Conductor BC-2LD1014762026-07-24
04260223147678Bone Conductor BC-2LD1014772026-07-24
04260223147746Ear Coupler TR1015062026-07-24
04260223147975PIEP (2x2)1013442026-07-24
04260223148002Accessory box AB-LT021013402026-07-24
04260223147326nanoAudio DD45101414-012025-08-05
04260223147333nanoAudio DD65v2101414-022025-08-05
04260223147340nanoAudio Patient Response Button1014202025-08-05
04260223147418Sentiero Screening 3100098-S32025-08-05
04260223147449nanoAudio DD45 Set101470-012025-08-05
04260223147456nanoAudio DD45 Set with Patient Response Button101470-022025-08-05
04260223147463nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake101470-032025-08-05
04260223147470nanoAudio DD65v2 Set101470-042025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260223148057Ear Coupler (Transparent) SetPATH medical GmbHGWJ2026-08-19
04260223147753Ear Coupler TR 30 pairsPATH medical GmbHGWJ2026-07-29
05711117244540InteracousticsInteracoustics A/SEWO2026-07-28
05711117244540InteracousticsInteracoustics A/SGWJ2026-07-28
05711117244557InteracousticsInteracoustics A/SETY2026-07-28
05711117244557InteracousticsInteracoustics A/SGWJ2026-07-28
05711117244557InteracousticsInteracoustics A/SEWO2026-07-28
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHEWO2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHEWO2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHEWO2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHEWO2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
057133150000581052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007511066 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
057133150007681052 OTOsuiteNatus Medical Denmark ApSEWO2026-06-22
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10