FDA 510(k)

Vivo 3

K 號：K240779 · 2024-12-13

決定日期2024-12-13

產品代碼MNT

諮詢委員會AN

決定相當於

器材摘要

Vivo 3 is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K240779. 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 Vivo 3?

Vivo 3 is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Breas Medical AB. The 510(k) number is K240779.

When did Vivo 3 receive FDA 510(k) clearance?

Vivo 3 received FDA 510(k) clearance on 2024-12-13, under 510(k) number K240779.

Who is the listed applicant for Vivo 3?

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

What is the FDA product code for Vivo 3?

The FDA product code for Vivo 3 is MNT.

其他以 Breas Medical AB 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。

K242485每物 K242438清朗 K233452Vivo 45 LS K240778Vivo 1, Vivo 2 K193586Vivo 45 LS K160481Vivo 60

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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。

K252182SV70呼吸器（SV70）Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K242931HFT750UMekics Co., Ltd.K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.K230173伺服空氣輕型呼吸器系統Maquet Critical Care AB K213521日本光電 NKV-330 呼吸器系統Nihon Kohden Orangemed, Inc.K191624F&P Nivairo RT047 通氣醫院全臉罩，防窒息閥版本Fisher & Paykel Healthcare Limited

官方來源

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