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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasound Guided Nerve Block Assist
510(k) Number K232787
Device Name ScanNav Anatomy Peripheral Nerve Block
Applicant
Intelligent Ultrasound Limited
Floor 6a, Hodge House, 114-116 St Mary Street
Cardiff,  GB CF101DY
Applicant Contact Bhaskar Chikkanna
Correspondent
Intelligent Ultrasound Limited
Floor 6a, Hodge House, 114-116 St Mary Street
Cardiff,  GB CF101DY
Correspondent Contact Bhaskar Chikkanna
Classification Product Code
QRG  
Date Received09/11/2023
Decision Date 10/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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