FDA 510(k) Application Details - DEN220024

Device Classification Name

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510(K) Number DEN220024
Device Name ScanNav Anatomy Peripheral Nerve Block
Applicant Intelligent Ultrasound Limited
Floor 6a, Hodge House, 114-116 St Mary Street
Cardiff CF10 1DY GB
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Contact Nicholas Sleep
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Regulation Number

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Classification Product Code QRG
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Date Received 04/08/2022
Decision Date 10/18/2022
Decision DENG -
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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