Eko Core Electronic Stethoscope

FDA UDI

Class II (US FDA UDI)

by Eko Devices, Inc.

Identity

Trade Name: Eko Core Electronic Stethoscope FDA UDI
Generic Name: Electronic acoustic stethoscope FDA UDI
Device Name: The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds. FDA UDI
Model / Reference: Model E4 FDA UDI
Description: The Eko Core Electronic Stethoscope is a complete electronic stethoscope with digital & analog capabilities that wirelessly pairs to the free Eko Mobile App for recording, visualization, sharing, and annotation of sounds. FDA UDI

Identifiers

Primary DI / UDI-DI: 00863609000303 FDA UDI
510(k) Number: K151319 FDA UDI
FDA Product Code: DQD FDA UDI
GMDN Term: Electronic acoustic stethoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1875 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electronic acoustic stethoscope

Eko Core Electronic Stethoscope by Eko Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electronic acoustic stethoscope.

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E-Scope — Cardionics, Inc. · Class II
Adscope® — American Diagnostic Corporation · Class II
TytoHome — TYTO CARE LTD · Class II
Adscope® — American Diagnostic Corporation · Class II
RNK Products — Rnk Products, Inc. · Class II
Steth IO Spot — Steth IO · Class II

Cleared under the same submission

K151319 also covers:

Eko Core Attachment — Eko Devices, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Eko Devices, Inc.

Sources (1)

FDA UDI 9ccf01cc-1791-4362-bf9c-2bb408712e12 34 fields · synced Jun 8, 2026