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510(k) K212100

Kosmos by EchoNous, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2021
Date Received
July 6, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by EchoNous, Inc.

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  • K181574 — Uscan (July 10, 2018)

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