FDA 510(k)

PRIMED 儿科面罩

K号: K213427 · 2022-11-22

决定日期2022-11-22

产品代码OXZ

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决定实质等同

器械摘要

PRIMED Pediatric Facemask is the device name listed in this FDA 510(k) record. The listed applicant is Primed Medical Products, Inc.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K213427. 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 PRIMED Pediatric Facemask?

PRIMED Pediatric Facemask is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Primed Medical Products, Inc.. The 510(k) number is K213427.

When did PRIMED Pediatric Facemask receive FDA 510(k) clearance?

PRIMED Pediatric Facemask received FDA 510(k) clearance on 2022-11-22, under 510(k) number K213427.

Who is the listed applicant for PRIMED Pediatric Facemask?

The FDA 510(k) record lists Primed Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMED Pediatric Facemask?

The FDA product code for PRIMED Pediatric Facemask is OXZ.

列明Primed Medical Products, Inc.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。

K262007PRIMED AAMI三级开放式背心式隔离衣 K261811PRIMED 化疗药物测试隔离服（PM4-99450：PRIMED 化疗药物测试隔离服，紫色，AAMI 级别 2；PM4-99460：PRIMED 化疗药物测试隔离服，蓝色，AAMI 级别 3）K252964PRIMED手术和手术用口罩 K242208PRIMED 消毒包装（P100，P200，P300，P400，P500，P600）K240286PRIMED手术口罩和PRIMED手术用口罩 K233777PRIMED 消毒包装（P100，P200，P300，P400，P500，P600）

查看所有 8 个设备 →

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.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.K160100Prestige Ameritech 儿科/儿童面罩Prestige Ameritech

官方来源

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