Eko CORE 500 Founder's Edition Chestpiece

FDA UDI

Class II (US FDA UDI)

by Eko Devices, Inc.

Identity

Trade Name: Eko CORE 500 Founder's Edition Chestpiece FDA UDI
Generic Name: Electronic acoustic stethoscope FDA UDI
Device Name: Eko CORE 500 Founder's Edition Chestpiece FDA UDI
Model / Reference: COR500FE FDA UDI
Description: Eko CORE 500 Founder's Edition Chestpiece FDA UDI

Identifiers

Catalog Number: COR500FE FDA UDI
Primary DI / UDI-DI: 00850010298214 FDA UDI
510(k) Number: K230111 FDA UDI
FDA Product Code: DQD FDA UDI
DPS FDA UDI
GMDN Term: Electronic acoustic stethoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1875 FDA UDI
870.2340 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Electronic acoustic stethoscope

Eko CORE 500 Founder's Edition Chestpiece by Eko Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K230111 also covers:

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 0f0037b7-75fc-44b6-a79d-ac314cf627cb 35 fields · synced Jun 8, 2026