FDA 510(k)

SV70呼吸器（SV70）

K 號：K252182 · 2026-04-06

申請人Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

決定日期2026-04-06

產品代碼MNT

諮詢委員會AN

決定相當於

器材摘要

SV70 Ventilator (SV70) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K252182. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SV70 Ventilator (SV70)?

SV70 Ventilator (SV70) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K252182.

When did SV70 Ventilator (SV70) receive FDA 510(k) clearance?

SV70 Ventilator (SV70) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K252182.

Who is the listed applicant for SV70 Ventilator (SV70)?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SV70 Ventilator (SV70)?

The FDA product code for SV70 Ventilator (SV70) is MNT.

其他以 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 為申請人之記錄

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相關器械（代碼：MNT）

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。

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