FDA 510(k)

Prestige Ameritech 儿科/儿童面罩

K号: K160100 · 2016-10-07

决定日期2016-10-07

产品代码OXZ

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Prestige Ameritech Pediatric/Child’s Face mask is the device name listed in this FDA 510(k) record. The listed applicant is Prestige Ameritech. It received FDA 510(k) clearance on 2016-10-07 under 510(k) number K160100. 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 Prestige Ameritech Pediatric/Child’s Face mask?

Prestige Ameritech Pediatric/Child’s Face mask is a medical device that received FDA 510(k) clearance on 2016-10-07. The listed applicant is Prestige Ameritech. The 510(k) number is K160100.

When did Prestige Ameritech Pediatric/Child’s Face mask receive FDA 510(k) clearance?

Prestige Ameritech Pediatric/Child’s Face mask received FDA 510(k) clearance on 2016-10-07, under 510(k) number K160100.

Who is the listed applicant for Prestige Ameritech Pediatric/Child’s Face mask?

The FDA 510(k) record lists Prestige Ameritech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prestige Ameritech Pediatric/Child’s Face mask?

The FDA product code for Prestige Ameritech Pediatric/Child’s Face mask is OXZ.

列明Prestige Ameritech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。

K231741ProGear® 氧化锌防护口罩，型号 AV82030 K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

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 K201514儿童面部口罩Shandong Shengquan New Material Co., Ltd.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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。