FDA 510(k)

N95 颗粒物呼吸器和手术口罩，型号 TN01-11 和 TN01-12

K号: K160271 · 2016-07-15

决定日期2016-07-15

产品代码MSH

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决定实质等同

器械摘要

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.

常见问题

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.

列明San-M Package Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K221534外科手术口罩（耳挂式和系带式）K160269外科手术口罩（耳挂式和系带式）

相关器械（代码：MSH）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233022Halyard Fluidshield 3 N95 颗粒物过滤呼吸器和手术口罩，带柔软衬里，橙色，常规和小号，Halyard Fluidshield 3 N95 颗粒物过滤呼吸器和手术口罩，带安全密封和柔软衬里，橙色，常规和小号，Halyard Fluidshield 2 N95 颗粒物过滤呼吸器和手术口罩，带柔软衬里，白色，常规和小号Owens & Minor (O&M) Halyard, Inc.K172963Master-Frank N95 颗粒物呼吸器Master & Frank Enterprise Co., Ltd.K1711163M® VFlex® Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M Healthcare

官方来源

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