Eko CORE 500 and CAC500 Founder's Edition bundle COR501FE

GUDID 00850010298207

Eko Devices, Inc.

Electronic stethoscope
Primary Device ID00850010298207
NIH Device Record Keyba569455-42e7-484c-bb11-e3e8cc6766be
Commercial Distribution StatusIn Commercial Distribution
Brand NameEko CORE 500 and CAC500 Founder's Edition bundle
Version Model NumberCOR501FE
Catalog NumberCOR501FE
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010298207 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-18
Device Publish Date2023-07-10