FDA 510(k)

N95 離子氣體呼吸器及外科口罩，型號 TN01-11 及 TN01-12

K 號：K160271 · 2016-07-15

決定日期2016-07-15

產品代碼MSH

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

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is the device name listed in this FDA 510(k) record. The listed applicant is San-M Package Co., Ltd.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K160271. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is San-M Package Co., Ltd.. The 510(k) number is K160271.

When did N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 receive FDA 510(k) clearance?

N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 received FDA 510(k) clearance on 2016-07-15, under 510(k) number K160271.

Who is the listed applicant for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

The FDA 510(k) record lists San-M Package Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12?

The FDA product code for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 is MSH.

其他以 San-M Package Co., Ltd. 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。

K221534外科口罩（耳環式與繫帶式）K160269外科口罩（耳環式和繫帶式）

相關器械（代碼：MSH）

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。

K233022Halyard Fluidshield 3 N95 離子過濾式呼吸器及外科口罩，內層柔軟，橙色，規格：普通型及小號，Halyard Fluidshield 3 N95 離子過濾式呼吸器及外科口罩，配安全封口及柔軟內層，橙色，規格：普通型及小號，Halyard Fluidshield 2 N95 離子過濾式呼吸器及外科口罩，內層柔軟，白色，規格：普通型及小號Owens & Minor (O&M) Halyard, Inc.K172963Master-Frank N95 離子氣體呼吸器Master & Frank Enterprise Co., Ltd.K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S3M Healthcare

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。