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 Number3011651230
FEI Number3011651230
NameEKO DEVICES, INC.
Owner & OperatorEko Devices, Inc.
Contact Address1212 Broadway Suite 100
Oakland CA 94612 US
Official Correspondent
  • Arezou Azar
  • 1-650-8040285-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1212 Broadway, Suite 100
Oakland, CA 94612 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Ruby Earpiece CAC500_RED2025-03-27
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Seaglass CAC500_FSG2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Dark Harbor CAC500_FDH2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Winning Red CAC500_FWR2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon CAC500_FPR2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Moss CAC500_FMO2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue CAC500_FRB2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone CAC500_FSA2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Mauve CAC500_FMA2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Grey CAC500_FGR2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope FIGS Earpiece - Black CAC500_FBL2025-03-26
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Amethyst Bundle COR501-PRP/PRP2025-03-25
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Sapphire Bundle COR501-BLU/BLU2025-03-25
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Wintergreen Bundle COR501-GRN/GRN2025-03-25
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Sapphire Chestpiece COR500_BLU2025-03-25
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Wintergreen Chestpiece COR500_GRN2025-03-25
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Sapphire Earpiece CAC500_BLU2025-03-25
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Wintergreen Earpiece CAC500_GRN2025-03-25
Eko Devices, Inc.
 EMAS (Eko Murmur Analysis Software) EMAS2025-03-25
Eko Devices, Inc.
 ELEFT (Eko Low Ejection Fraction Tool) ELEFT2025-03-25
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Amethyst Chestpiece COR500_PRP2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Amethyst Earpiece CAC500_PRP2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Incase Bundle (Black) COR502-BLK/BLK2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Black Earpiece CAC500_BLK2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Incase Bundle COR502-SLV/SLV2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Champagne Bundle COR501-CHP/CHP2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Champagne Earpiece CAC500_CHP2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Champagne Chestpiece COR500_CHP2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Black Bundle COR501-BLK/BLK2025-03-20
Eko Devices, Inc.
 CORE 500 Digital Stethoscope - Black Chestpiece COR500_Black2025-03-20
Eko Devices, Inc.
 Eko CORE 500 Founder's Edition Chestpiece COR500FE2023-07-18
Eko Devices, Inc.
 Eko CORE 500 and CAC500 Founder's Edition bundle COR501FE2023-07-18
Eko Devices, Inc.
 Eko CORE 500 and CAC500 Standard bundle COR5012023-07-18
Eko Devices, Inc.
 Eko CORE 500 Digital Stethoscope Earpiece CAC5002023-07-18
Eko Devices, Inc.
 Eko CORE 500 Digital Stethoscope Chestpiece COR5002023-07-18
Eko Devices, Inc.
Eko Murmur Analysis Software (EMAS)2022-06-29
Eko Devices, Inc.
 Eko Mobile App Android International 2021-04-20
EKO DEVICES, INC.
 Eko Analysis Software 2020-09-16
EKO DEVICES, INC.
 Eko Core Digital Stethoscope 2020-05-08
EKO DEVICES, INC.
 Eko Core Digital Attachment 2020-05-08
Eko Devices, Inc.
Eko CORE2020-04-06
Eko Devices Inc
Eko Analysis Software2020-01-15
EKO DEVICES, INC.
 Eko App Windows 2018-11-08
EKO DEVICES, INC.
 Eko Mobile App Android 2018-11-08
EKO DEVICES, INC.
 Eko Mobile App iOS 2018-11-08
EKO DEVICES, INC.
 DUO 2018-08-16
EKO DEVICES, INC.
DUO2018-04-20
EKO DEVICES, INC.
DUO2018-04-20
EKO DEVICES, INC.
 Eko Core Attachment 2018-03-29
EKO DEVICES, INC.
 Eko Core Electronic Stethoscope 2018-03-29
Eko Devices, Inc.
Eko Model E5 System (EME5), Eko DUO2017-05-19
Eko Devices, Inc.
Eko Electronic Stethoscope System2015-08-28

Related Finance Registrations
NCAGE Code7KDF2EKO DEVICES, INC.
CAGE Code7KDF2EKO DEVICES, INC. EKO DEVICES
S.A.M. Registration7KDF2 [79670921]EKO DEVICES, INC. EKO DEVICES
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092221008Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaDIGITAL STETHOSCOPE38 CTN
2020091928201Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaDIGITAL STETHOSCOPE38 CTN
2020091223790Yantian,China (Mainland) -> Oakland, CaliforniaTOP CASE(STETHOSCOPE PART)288 CTN
2020091129650Yantian,China (Mainland) -> Oakland, CaliforniaTOP CASE(STETHOSCOPE PART)288 CTN
2020090533652Yantian,China (Mainland) -> Oakland, CaliforniaTOP CASE(STETHOSCOPE PART)288 CTN
2020041551958Yantian,China (Mainland) -> Oakland, CaliforniaEARPIECE BOX EP TRAY CHARGING BOARDNO WOOD PACKING MATERIAL IS USED IN THE SHIPMENT188 CTN
2020021733745Yantian,China (Mainland) -> Oakland, CaliforniaEARPIECE TOP BOX144 CTN
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