FDA 510(k)

N95粒子呼吸器および手術マスク、モデルTN01-11およびTN01-12

K番号: K160271 · 2016-07-15

決定日2016-07-15

製品コードMSH

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてSan-M Package Co., Ltd.を記載するその他の記録

K221534手術用マスク（耳ひも式および留め具式）K160269手術用マスク（耳ひも式および留め具式）

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