DUO

GUDID 00863609000327

EKO DEVICES, INC.

Electronic stethoscope
Primary Device ID00863609000327
NIH Device Record Key970b4038-8e07-4c14-8ede-21ac9fec8def
Commercial Distribution StatusIn Commercial Distribution
Brand NameDUO
Version Model NumberE5
Company DUNS079670921
Company NameEKO DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS100863609000327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-16
Device Publish Date2018-07-16

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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