FDA 510(k)

CIRCA MATRIX12 M 食道温度プローブおよび温度監視システム

K番号: K222311 · 2023-05-25

決定日2023-05-25

製品コードFLL

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K222311. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K222311.

When did CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System receive FDA 510(k) clearance?

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System received FDA 510(k) clearance on 2023-05-25, under 510(k) number K222311.

Who is the listed applicant for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

The FDA 510(k) record lists Circa Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

The FDA product code for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is FLL.

申請者としてCirca Scientific, Inc.を記載するその他の記録

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