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FDA 510(k)

Safecare 开背防护服和 ValueCare 开背防护服

K号: K160337 · 2017-07-07

申请人Bam Corporation Limited
决定日期2017-07-07
产品代码QPC
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决定实质等同

器械摘要

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns is the device name listed in this FDA 510(k) record. The listed applicant is Bam Corporation Limited. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K160337. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Bam Corporation Limited. The 510(k) number is K160337.

When did Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns receive FDA 510(k) clearance?

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns received FDA 510(k) clearance on 2017-07-07, under 510(k) number K160337.

Who is the listed applicant for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

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

What is the FDA product code for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

The FDA product code for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns is QPC.

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

相关器械（代码：QPC）

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PRIMED Medical Products, Inc.K261115VR®个人防护级4级隔离服（VR隔离服）PolyConversions, Inc.K252940VR®个人防护三级隔离服（VR隔离服）PolyConversions, Inc.K242689AAMI 级别 4 保护服；外衣Azac GroupK233526Medline 开背式三级防护服Medline Industries, LPK230384PolyWear® 个人防护三级隔离服PolyConversions, Inc.

官方来源

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