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FDA 510(k)

Medicom 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)

K号: K190308 · 2019-09-17

申请人Amd Medicom, Inc.
决定日期2019-09-17
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

Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) is the device name listed in this FDA 510(k) record. The listed applicant is Amd Medicom, Inc.. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K190308. 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 Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)?

Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is Amd Medicom, Inc.. The 510(k) number is K190308.

When did Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) receive FDA 510(k) clearance?

Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) received FDA 510(k) clearance on 2019-09-17, under 510(k) number K190308.

Who is the listed applicant for Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)?

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

What is the FDA product code for Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)?

The FDA product code for Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) is OXZ.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Amd Medicom, 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。

K190306AMD Ritmed AssureWear VersaGown

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 CorporationK201514儿童面部口罩Shandong Shengquan New Material Co., Ltd.K202831iMask儿童面罩。Pac-Dent, Inc.K160100Prestige Ameritech 儿科/儿童面罩Prestige Ameritech

官方来源

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