FDA device listing

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert,CMN Capillary Function with Virtual Expert

FDA device listing 1755322775 · Cercare Medical

Key facts

Proprietary names Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert,CMN Capillary Function with Virtual Expert
Owner/operator Cercare Medical
Owner/operator number 10082009
Premarket submissions K241989
Product codes LLZ
Device names LLZ - System, Image Processing, Radiological
Device class Class II
Classification regulations (21 CFR) 892.2050
Review panels Radiology
Registered establishments CERCARE MEDICAL A/S
Establishment registrations 3019844085
FEI numbers 3019844085
Establishment operations Complaint File Establishment, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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