Eko CORE 500 Founder's Edition Chestpiece COR500FE

GUDID 00850010298214

Eko CORE 500 Founder's Edition Chestpiece

Eko Devices, Inc.

Electronic stethoscope
Primary Device ID00850010298214
NIH Device Record Key0f0037b7-75fc-44b6-a79d-ac314cf627cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEko CORE 500 Founder's Edition Chestpiece
Version Model NumberCOR500FE
Catalog NumberCOR500FE
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 Datetrue
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
GS100850010298214 [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