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FDA 510(k)

Cercare Medical Neurosuite

K-Number: K230016 · 2023-07-14

ApplicantCercare Medical A/S
Decision Date2023-07-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Cercare Medical Neurosuite is the device name listed in this FDA 510(k) record. The listed applicant is Cercare Medical A/S. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K230016. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cercare Medical Neurosuite?

Cercare Medical Neurosuite is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Cercare Medical A/S. The 510(k) number is K230016.

When did Cercare Medical Neurosuite receive FDA 510(k) clearance?

Cercare Medical Neurosuite received FDA 510(k) clearance on 2023-07-14, under 510(k) number K230016.

Who is the listed applicant for Cercare Medical Neurosuite?

The FDA 510(k) record lists Cercare Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cercare Medical Neurosuite?

The FDA product code for Cercare Medical Neurosuite is LLZ.

Other records listing Cercare Medical A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260316CMN Capillary Function with Oncology Virtual ExpertK253831CMN Capillary Function with Virtual Expert for MRI, CT and CBCTK241989Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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