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FDA 510(k)

热成型片材（A通道）；热成型片材（B通道）；热成型片材（E通道）；热成型片材（漂白B通道）

K号: K241311 · 2024-08-02

申请人Bernhard Förster GmbH
决定日期2024-08-02
产品代码MQC
决定实质等同

器械摘要

Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) is the device name listed in this FDA 510(k) record. The listed applicant is Bernhard Förster GmbH. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241311. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)?

Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Bernhard Förster GmbH. The 510(k) number is K241311.

When did Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) receive FDA 510(k) clearance?

Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241311.

Who is the listed applicant for Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)?

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

What is the FDA product code for Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)?

The FDA product code for Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) is MQC.

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：MQC）

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。

K253798UltraPrint-Dental 硬式牙科夹板 紫外线Guangzhou Heygears IMC., Inc.K250743Remvia 夜间护牙器RemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729硬夹板与热适应性夹板Whip Mix CorporationK243516Remi定制夜间牙套Grindguard, Inc.K241369LIJIA 夜间护牙器Lijia, LLC

官方来源

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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。

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