FDA.reportPublic FDA data

510(k) K230016

Device
Cercare Medical Neurosuite
Applicant
Cercare Medical A/S
510(k) number
K230016
Product code
LLZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-14
Date received
2023-01-03
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Peter Loekke
Address
Inge Lehmanns Gade 10 Aarhus DK DK-8000 DK-8000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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