FDA 510(k)

MolecuLight i:X

K 號：K191371 · 2019-12-04

決定日期2019-12-04

產品代碼QJF

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

MolecuLight i:X is the device name listed in this FDA 510(k) record. The listed applicant is MolecuLight, Inc.. It received FDA 510(k) clearance on 2019-12-04 under 510(k) number K191371. The device is classified under product code QJF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MolecuLight i:X?

MolecuLight i:X is a medical device that received FDA 510(k) clearance on 2019-12-04. The listed applicant is MolecuLight, Inc.. The 510(k) number is K191371.

When did MolecuLight i:X receive FDA 510(k) clearance?

MolecuLight i:X received FDA 510(k) clearance on 2019-12-04, under 510(k) number K191371.

Who is the listed applicant for MolecuLight i:X?

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

What is the FDA product code for MolecuLight i:X?

The FDA product code for MolecuLight i:X is QJF.

其他以 MolecuLight, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K213840MolecuLight I:X K211901MolecuLightDX K210882MolecuLight I:X

相關器械（代碼：QJF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251678Swift Ray 1Swift Medical, Inc.K242669SnapshotGLO (KB100)Kent Imaging, Inc.K230734多光谱攝影套件（MSI 套件）(300-00015)，多光谱攝影機（MSI）(300-00009)Precision Healing, LLC K213840MolecuLight I:XMolecuLight, Inc.K211901MolecuLightDXMolecuLight, Inc.K210882MolecuLight I:XMolecuLight, Inc.

官方來源

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