KOSMOS

System, Imaging, Pulsed Doppler, Ultrasonic

EchoNous, Inc.

The following data is part of a premarket notification filed by Echonous, Inc. with the FDA for Kosmos.

Pre-market Notification Details

• Device ID: K193518
• 510k Number: K193518
• Device Name: KOSMOS
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: EchoNous, Inc. 8310 154th Ave NE, Bldg B, Ste 200 Redmond, WA 98052
• Contact: Trish Liau
• Correspondent: Trish Liau; EchoNous, Inc. 8310 154th Ave NE, Bldg B, Ste 200 Redmond, WA 98052
• Product Code: IYN
• Subsequent Product Code: DPS
• Subsequent Product Code: DQD
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-19
• Decision Date: 2020-03-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09353278000267	K193518	000
09353278000502	K193518	000
09353278000519	K193518	000
09353278000588	K193518	000
09353278000571	K193518	000
09353278000625	K193518	000
09353278000694	K193518	000
09353278000687	K193518	000
09353278000700	K193518	000
09353278000717	K193518	000
09353278000434	K193518	000
09353278000441	K193518	000
09353278000250	K193518	000
09353278000243	K193518	000
09353278000212	K193518	000
09353278000144	K193518	000
09353278000137	K193518	000
09353278000120	K193518	000
09353278000489	K193518	000
09353278000465	K193518	000
09353278000458	K193518	000
09353278000762	K193518	000