Eko Core Electronic Stethoscope

GUDID 00863609000303

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.

EKO DEVICES, INC.

Electronic stethoscope
Primary Device ID00863609000303
NIH Device Record Key9ccf01cc-1791-4362-bf9c-2bb408712e12
Commercial Distribution StatusIn Commercial Distribution
Brand NameEko Core Electronic Stethoscope
Version Model NumberModel E4
Company DUNS079670921
Company NameEKO DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100863609000303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQDStethoscope, Electronic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-26

Devices Manufactured by EKO DEVICES, INC.

00850010298160 - Eko CORE 500 Digital Stethoscope Chestpiece2023-07-18 Eko CORE 500 Digital Stethoscope Chestpiece
00850010298177 - Eko CORE 500 Digital Stethoscope Earpiece 2023-07-18
00850010298191 - Eko CORE 500 and CAC500 Standard bundle2023-07-18 Eko CORE 500 and CAC500 Standard bundle
00850010298207 - Eko CORE 500 and CAC500 Founder's Edition bundle2023-07-18
00850010298214 - Eko CORE 500 Founder's Edition Chestpiece2023-07-18 Eko CORE 500 Founder's Edition Chestpiece
00850010298061 - Eko Mobile App Android International2021-04-20 Eko mobile app for android international platforms for use with Eko medical devices.
00850010298030 - Eko Analysis Software2020-09-16 The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’
00850010298009 - Eko Core Digital Attachment2020-05-08 The Eko Core Attachment connects to (and digitizes) the analog stethoscope you already own. It attaches to almost all single-tub

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