FDA.reportPublic FDA data

ALGO Pro

Primary DI
00382830061896
Brand
ALGO Pro
Company
XLTEK
Model
036244
Device description
ALGO Pro Docking Station
Published
2024-03-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830061896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830061896003828300618963828300618960382830061896

GMDN Terms#

Term, Definition table
TermDefinition
Auditory stimulatorA mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and auditory function screening devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
245258280
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830063890Natus047528-W2026-10-15
00382830063821Natus046795-W2026-10-15
00382830063838Natus046796-W2026-10-15
00382830063845Natus046797-W2026-10-15
00382830063852Natus046798-W2026-10-15
00382830063869Natus046799-W2026-10-15
00382830063876Natus046800-W2026-10-15
00382830063883Natus051313-W2026-10-15
00382830063906Natus047543-W2026-10-15
00382830063913Natus046781-W2026-10-15
00382830063920Natus046782-W2026-10-15
00382830063937Natus046783-W2026-10-15
00382830023955Natus20130012025-02-27
00382830023986Natus20400012025-02-27
00382830059251Natus20200112025-02-27
00382830062466Natus60-0000702024-09-30
00382830016896Natus61-0004002021-06-22
00382830056335Natus61-0003002021-06-22
00382830058674Natus60-0000902021-06-22
00382830058681Natus60-0000922021-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713315010996AccuScreen EarcouplersNatus Medical Denmark ApSGWJ2026-10-14
05713315011009AccuScreen EarcouplersNatus Medical Denmark ApSGWJ2026-10-14
05713315012297Disposable Snap Electrodes (25 x 3 pack)Natus Medical Denmark ApSGWJ2026-10-14
05713315012303Disposable Snap Electrodes (3 pack)Natus Medical Denmark ApSGWJ2026-10-14
00810046707265Grason-StadlerDiagnostic Group LLCGWJ2026-09-29
04260223148057Ear Coupler (Transparent) SetPATH medical GmbHGWJ2026-08-19
04260223147753Ear Coupler TR 30 pairsPATH medical GmbHGWJ2026-07-29
05711117244540InteracousticsInteracoustics A/SGWJ2026-07-28
05711117244557InteracousticsInteracoustics A/SGWJ2026-07-28
04260223145995Ear Coupler SetPATH medical GmbHGWJ2026-07-24
04260223147579Infant Insert Eartips 4.0mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147586Infant Insert Eartips 3.5mm (bag of 20)PATH medical GmbHGWJ2026-07-24
04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
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
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
B592SW100WAVi Scan SoftwareWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22