FDA 510(k)

Viva鼻罩（型號：NM4），Numa全臉罩（型號：BMC-FM2）

K 號：K163464 · 2017-09-05

決定日期2017-09-05

產品代碼BZD

諮詢委員會AN

決定相當於

器材摘要

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is the device name listed in this FDA 510(k) record. The listed applicant is Bmc Medical., Ltd.. It received FDA 510(k) clearance on 2017-09-05 under 510(k) number K163464. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is a medical device that received FDA 510(k) clearance on 2017-09-05. The listed applicant is Bmc Medical., Ltd.. The 510(k) number is K163464.

When did Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) receive FDA 510(k) clearance?

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) received FDA 510(k) clearance on 2017-09-05, under 510(k) number K163464.

Who is the listed applicant for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

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

What is the FDA product code for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

The FDA product code for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is BZD.

相關器械（代碼：BZD）

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。

K261262Altis 全面罩Respironics, Inc.K253044RXiBreeze PAP系統（RXiBreeze 20C）Resvent Medical Technology Co., Ltd.K253553歐里安Resmed Corp K254104ResScan 基礎版Resmed Corp K251920睡眠呼吸中止症呼吸治療面罩：JoyMask 20-B 全面罩，JoyMask 21-B 全面罩Dcstar, Inc.K253166F6S 全面罩 (F6S)；P6S 鼻枕接口 (P6S)BMC Medical Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：BZD）

官方來源