FDA 510(k)

Cercare Medical Neurosuite（CMN）毛細機能とバーチャルエキスパート

K番号: K241989 · 2024-12-06

決定日2024-12-06

製品コードLLZ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert 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 2024-12-06 under 510(k) number K241989. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert?

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Cercare Medical A/S. The 510(k) number is K241989.

When did Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert receive FDA 510(k) clearance?

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241989.

Who is the listed applicant for Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert?

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 (CMN) Capillary Function with Virtual Expert?

The FDA product code for Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is LLZ.

申請者としてCercare Medical A/Sを記載するその他の記録

K260316CMN毛細血管機能および腫瘍学バーチャルエキスパート K253831CMN毛細血管機能とMRI、CTおよびCBCT用バーチャルエキスパート K230016Cercare メディカルネウロスイート

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