FDA.reportPublic FDA data

ECHONOUS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30137576963013757696ECHONOUS, INC.1N2026-01-018310 154th Ave NE Building B, Suite 200 Redmond WA US 98052

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2099251223021265K242321KosmosIYN2025-04-25
2099251333677075K233826KosmosIYN2024-08-29
2099251858347877K212100KosmosIYN2021-08-06
2099251292338074K193518KOSMOSIYN2020-03-26
2099251379892087K181574UscanIYO2018-07-10
2099251590078216K160420SpeqTIYO2016-03-21
2099251472806609K090505SPEQ ULTRASOUND SYSTEMIYO2009-05-07
2099251006516183

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN42025-04-25
IYO32018-07-10

PMN#

Kosmos

2025-04-25

EchoNous, Inc.

Kosmos

2024-08-29

EchoNous, Inc.

Kosmos

2021-08-06

EchoNous, Inc.

KOSMOS

2020-03-26

EchoNous, Inc.

Uscan

2018-07-10

EchoNous, Inc.

GUDID#

59 records. Showing 1-40. Next