Eko Devices Inc

FDA Filings

This page includes the latest FDA filings for Eko Devices Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011651230
• FEI Number: 3011651230
• Name: EKO DEVICES, INC.
• Owner & Operator: Eko Devices, Inc.
• Contact Address: 1212 Broadway Suite 100; Oakland CA 94612 US
• Official Correspondent:
  • Arezou Azar
  • 1-650-8040285-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1212 Broadway, Suite 100 ; Oakland, CA 94612 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00850010298214 Eko Devices, Inc.	Eko CORE 500 Founder's Edition Chestpiece COR500FE	2023-07-18
GUDID 00850010298207 Eko Devices, Inc.	Eko CORE 500 and CAC500 Founder's Edition bundle COR501FE	2023-07-18
GUDID 00850010298191 Eko Devices, Inc.	Eko CORE 500 and CAC500 Standard bundle COR501	2023-07-18
GUDID 00850010298177 Eko Devices, Inc.	Eko CORE 500 Digital Stethoscope Earpiece CAC500	2023-07-18
GUDID 00850010298160 Eko Devices, Inc.	Eko CORE 500 Digital Stethoscope Chestpiece COR500	2023-07-18
PMN K213794 Eko Devices, Inc.	Eko Murmur Analysis Software (EMAS)	2022-06-29
GUDID 00850010298061 Eko Devices, Inc.	Eko Mobile App Android International	2021-04-20
GUDID 00850010298030 EKO DEVICES, INC.	Eko Analysis Software	2020-09-16
GUDID 00850010298016 EKO DEVICES, INC.	Eko Core Digital Stethoscope	2020-05-08
GUDID 00850010298009 EKO DEVICES, INC.	Eko Core Digital Attachment	2020-05-08
PMN K200776 Eko Devices, Inc.	Eko CORE	2020-04-06
PMN K192004 Eko Devices Inc	Eko Analysis Software	2020-01-15
GUDID 00863609000358 EKO DEVICES, INC.	Eko App Windows	2018-11-08
GUDID 00863609000341 EKO DEVICES, INC.	Eko Mobile App Android	2018-11-08
GUDID 00863609000334 EKO DEVICES, INC.	Eko Mobile App iOS	2018-11-08
GUDID 00863609000327 EKO DEVICES, INC.	DUO	2018-08-16
PMN K170874 | DQD EKO DEVICES, INC.	DUO	2018-04-20
PMN K170874 | DPS EKO DEVICES, INC.	DUO	2018-04-20
GUDID 00863609000310 EKO DEVICES, INC.	Eko Core Attachment	2018-03-29
GUDID 00863609000303 EKO DEVICES, INC.	Eko Core Electronic Stethoscope	2018-03-29
PMN K170874 Eko Devices, Inc.	Eko Model E5 System (EME5), Eko DUO	2017-05-19
PMN K151319 Eko Devices, Inc.	Eko Electronic Stethoscope System	2015-08-28

Related Finance Registrations

NCAGE Code	7KDF2	EKO DEVICES, INC.
CAGE Code	7KDF2	EKO DEVICES, INC. EKO DEVICES
S.A.M. Registration	7KDF2 [79670921]	EKO DEVICES, INC. EKO DEVICES

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092221008	Kaohsiung,China (Taiwan) -> Los Angeles, California	DIGITAL STETHOSCOPE	38 CTN
2020091928201	Kaohsiung,China (Taiwan) -> Los Angeles, California	DIGITAL STETHOSCOPE	38 CTN
2020091223790	Yantian,China (Mainland) -> Oakland, California	TOP CASE(STETHOSCOPE PART)	288 CTN
2020091129650	Yantian,China (Mainland) -> Oakland, California	TOP CASE(STETHOSCOPE PART)	288 CTN
2020090533652	Yantian,China (Mainland) -> Oakland, California	TOP CASE(STETHOSCOPE PART)	288 CTN
2020041551958	Yantian,China (Mainland) -> Oakland, California	EARPIECE BOX EP TRAY CHARGING BOARDNO WOOD PACKING MATERIAL IS USED IN THE SHIPMENT	188 CTN
2020021733745	Yantian,China (Mainland) -> Oakland, California	EARPIECE TOP BOX	144 CTN