510(k) DEN220024

Device
ScanNav Anatomy Peripheral Nerve Block
Applicant
Intelligent Ultrasound Limited
510(k) number
DEN220024
Product code
QRG
Decision
Unknown (DENG)
Decision date
2022-10-18
Date received
2022-04-08
Regulation
868.1980
Classification name
Ultrasound Guided Nerve Block Assist
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Direct
Third party reviewed
N

Applicant Contact#

Contact
Nicholas Sleep
Address
Floor 6a, Hodge House, 114-116 St. Mary St. Cardiff GB CF10 1DY CF10 1DY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QRG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250818NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S.2025-08-15
K232787ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited2023-10-06