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: K212100
• 510k Number: K212100
• Device Name: Kosmos
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: EchoNous, Inc. 8310 154th Ave NE, Building B, Suite 200 Redmond, WA 98052
• Contact: Carly Hom
• Correspondent: Prithul Bom; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• 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: Yes
• Combination Product: No
• Date Received: 2021-07-06
• Decision Date: 2021-08-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09353278000618	K212100	000
09353278000595	K212100	000
09353278000724	K212100	000
09353278000632	K212100	000