FDA 510(k)

儿童面部口罩

K号: K201514 · 2021-10-10

申请人Shandong Shengquan New Material Co., Ltd.

决定日期2021-10-10

产品代码OXZ

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决定实质等同

器械摘要

Child Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Shengquan New Material Co., Ltd.. It received FDA 510(k) clearance on 2021-10-10 under 510(k) number K201514. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Child Face Mask?

Child Face Mask is a medical device that received FDA 510(k) clearance on 2021-10-10. The listed applicant is Shandong Shengquan New Material Co., Ltd.. The 510(k) number is K201514.

When did Child Face Mask receive FDA 510(k) clearance?

Child Face Mask received FDA 510(k) clearance on 2021-10-10, under 510(k) number K201514.

Who is the listed applicant for Child Face Mask?

The FDA 510(k) record lists Shandong Shengquan New Material Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Child Face Mask?

The FDA product code for Child Face Mask is OXZ.

列明Shandong Shengquan New Material 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。

K201629医疗口罩 K201537医用防护口罩

相关器械（代码：OXZ）

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。

K221753Kangbeier儿童手术口罩Xinxiang Kangbeier Medical Technology Co., Ltd.K213427PRIMED 儿科面罩Primed Medical Products, Inc.K210321Dukal Corporation Level 1 儿科面部口罩Dukal Corporation K202831iMask儿童面罩。Pac-Dent, Inc.K190308Medicom 安全口罩 Sofskin 儿童手术耳带口罩 (ASTM Level 1)，Medicom 安全口罩 Sofskin 儿童手术耳带口罩，Medicom 安全口罩 Premier 儿童手术耳带口罩 (ASTM Level 1)，Medicom 安全口罩 Premier 儿童手术耳带口罩 (ASTM Level 1)Amd Medicom, Inc.K160100Prestige Ameritech 儿科/儿童面罩Prestige Ameritech

官方来源

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