FDA.reportPublic FDA data

CORE 500 Digital Stethoscope - Bundle-CHP

Primary DI
00850010298801
Brand
CORE 500 Digital Stethoscope - Bundle-CHP
Company
Eko Devices, Inc.
Model
E8
Catalog number
COR503-CHP/CHP
Device description
CORE 500 Digital Stethoscope - Bundle-CHP
Published
2025-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

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
00850010298801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010298801008500102988018500102988010850010298801

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)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079670921
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkE8CAC500_FRP2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyE8CAC500_FOT2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceE8COR500_ROG2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceE8CAC500_ROG2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGE8COR503-ROG/ROG2026-04-03
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueE8CAC500_FCB2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)1.x.xEFAST2026-01-29
00850010298146ELEFT (Eko Low Ejection Fraction Tool)v7.xELEFT2025-03-17
00850010298184EMAS (Eko Murmur Analysis Software) Version 1.xEMAS2025-03-17
00850010298030Eko Analysis SoftwareEAS2020-09-08
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceE8COR500_CBL2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceE8CAC500_CBL2025-11-07
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceE8COR500_RED2025-10-15
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryE8CAC500_FEL2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteE8CAC500_FOW2025-10-15
00850010298726CORE 500 Digital Stethoscope - Electric Pink ChestpieceE8COR500_PNK2025-08-12
00850010298757CORE 500 Digital Stethoscope - Electric Pink EarpieceE8CAC500_PNK2025-08-12
00850010298788CORE 500 Digital Stethoscope - Bundle-SLVE8COR503-SLV/SLV2025-08-12
00850010298795CORE 500 Digital Stethoscope - Bundle-BLKE8COR503-BLK/BLK2025-08-12
00850010298818CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club PinkE8CAC500_FMG2025-08-12

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08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-05-18