FDA 510(k)

M-Wave

K 號：K233485 · 2024-01-26

決定日期2024-01-26

產品代碼IPF

諮詢委員會PM

決定相當於

器材摘要

M-Wave is the device name listed in this FDA 510(k) record. The listed applicant is Zynex Medical, Inc.. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K233485. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the M-Wave?

M-Wave is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Zynex Medical, Inc.. The 510(k) number is K233485.

When did M-Wave receive FDA 510(k) clearance?

M-Wave received FDA 510(k) clearance on 2024-01-26, under 510(k) number K233485.

Who is the listed applicant for M-Wave?

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

What is the FDA product code for M-Wave?

The FDA product code for M-Wave is IPF.

其他以 Zynex Medical, 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。

K223217Zynex監控系統，型號CM-1600 K191697心臟監護器 1500

相關器械（代碼：IPF）

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。

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816高頻功率治療法（HiToP）（型號：HiToP PNP）Mohammadali Nezakati K260142StimelMD (SSMD) 系統Motion Informatics ltd.K251083精巧IIEnraf-Nonius, B.V.K241433EVE 統合（EVE-20M）Weero Co., Ltd.K241488TrainFES先進版Trainfes

官方來源

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