FDA.reportPublic FDA data

CORE 500 Digital Stethoscope - Ember Chestpiece

Primary DI
00810209880187
Brand
CORE 500 Digital Stethoscope - Ember Chestpiece
Company
Eko Health, Inc.
Model
E8
Device description
The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users). A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.
Published
2026-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQDStethoscope, Electronic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQDStethoscope, ElectronicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233609000CORE 500 Digital StethoscopeEko Health, Inc.2024-03-28DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810209880187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810209880187008102098801878102098801870810209880187

GMDN Terms#

Term, Definition table
TermDefinition
Electronic acoustic stethoscopeAn external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].

Regulatory Flags#

DUNS number
079670921
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceE82026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoE82026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedE82026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackE102026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryE102026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetE102026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificE102026-10-01
00810209880255CORE 300™ Digital Stethoscope - CloudE102026-10-01
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceE8CAC500_ENB2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceE8CAC500_EMG2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleE8COR501-SLV/ENB2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleE8COR501-BLK/EMG2026-06-12
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkE8CAC500_FRP2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyE8CAC500_FOT2026-04-03
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceE8COR500_RED2025-10-15
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceE8COR500_CBL2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceE8CAC500_CBL2025-11-07
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryE8CAC500_FEL2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteE8CAC500_FOW2025-10-15
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceE8COR500_ROG2026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DQD2026-10-01
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DPS2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DPS2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DQD2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DQD2026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackEko Health, Inc.DQD2026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryEko Health, Inc.DQD2026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetEko Health, Inc.DQD2026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificEko Health, Inc.DQD2026-10-01
00810209880255CORE 300™ Digital Stethoscope - CloudEko Health, Inc.DQD2026-10-01
06944413835153Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
00884838096738Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
00884838096745Cardiac WorkstationPhilips Medizin Systeme Böblingen GmbHDPS2026-08-18
06944413844919SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
06944413847422SE-1202 Series ElectrocardiographEdan Instruments, Inc.DPS2026-07-21
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DPS2026-07-16
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-06-22
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DQD2026-06-12
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DPS2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DPS2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DQD2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DPS2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DQD2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DPS2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DQD2026-06-12
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DQD2026-06-03
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DPS2026-06-03