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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 St.
Cardiff,  GB CF101DY
Applicant Contact Bhaskar Chikkanna
Correspondent
Intelligent Ultrasound Limited
Floor 6a, Hodge House, 114-116 St. Mary St.
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
Predetermined Change
Control Plan Authorized		 No
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