FDA.reportPublic FDA data

Stethee Pro

Primary DI
09351356000017
Brand
Stethee Pro
Company
M3DICINE PTY LTD
Model
1
Device description
The M3DICINE Stethee™ Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment. Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable sample recording, playback, visualization, analysis, reporting and sharing with other authorized users.
Published
2020-04-23
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
DQDStethoscope, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQDStethoscope, ElectronicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172296000
K193631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172296000Stethee ProM3Dicine Pty , Ltd.2017-10-30DQD
K193631000Stethee Pro 1, Stethee Pro Software SystemM3Dicine Pty , Ltd.2020-10-09DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351356000017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351356000017093513560000179351356000017

GMDN Terms#

Term, Definition table
TermDefinition
Electronic stethoscopeAn external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. It will typically be connected to a computer so that the results can be presented on a screen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
757852710
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351356000031Stethee Pro Mobile Android Application2.0.X2020-12-23
09351356000048Stethee Pro Mobile iOS Application2.0.X2020-12-23
09351356000055Stethee Pro Central Web Application 2.0.X2020-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DQD2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DQD2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-05-18
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DQD2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Devices, Inc.DQD2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceEko Devices, Inc.DQD2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceEko Devices, Inc.DQD2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGEko Devices, Inc.DQD2026-04-03
00860011561736Stethophone ProSparrow Acoustics Inc.DQD2026-02-18
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Devices, Inc.DQD2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Devices, Inc.DQD2026-01-29
08809427311032SkeeperSmartsound CorportationDQD2026-01-12
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceEko Devices, Inc.DQD2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceEko Devices, Inc.DQD2025-11-07
06429811134003Keikku Digital StethoscopeLapsi Health Holding B.V.DQD2025-10-16
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceEko Devices, Inc.DQD2025-10-15
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryEko Devices, Inc.DQD2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteEko Devices, Inc.DQD2025-10-15
00850010298726CORE 500 Digital Stethoscope - Electric Pink ChestpieceEko Devices, Inc.DQD2025-08-12
00850010298757CORE 500 Digital Stethoscope - Electric Pink EarpieceEko Devices, Inc.DQD2025-08-12
00850010298788CORE 500 Digital Stethoscope - Bundle-SLVEko Devices, Inc.DQD2025-08-12
00850010298795CORE 500 Digital Stethoscope - Bundle-BLKEko Devices, Inc.DQD2025-08-12
00850010298801CORE 500 Digital Stethoscope - Bundle-CHPEko Devices, Inc.DQD2025-08-12
00850010298818CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club PinkEko Devices, Inc.DQD2025-08-12
00850010298733CORE 500 Digital Stethoscope - Ruby Earpiece Eko Devices, Inc.DQD2025-03-19
00850010298245CORE 500 Digital Stethoscope FIGS Earpiece - BlackEko Devices, Inc.DQD2025-03-18
00850010298252CORE 500 Digital Stethoscope FIGS Earpiece - GreyEko Devices, Inc.DQD2025-03-18
00850010298269CORE 500 Digital Stethoscope FIGS Earpiece - MauveEko Devices, Inc.DQD2025-03-18