FDA 510(k)

DORO LUCENT颅骨夹（1101.001）；DORO LUCENT颅骨夹儿童套装（1101.040）

K号: K240319 · 2024-04-24

决定日期2024-04-24

产品代码HBL

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) is the device name listed in this FDA 510(k) record. The listed applicant is Pro Med Instruments GmbH. It received FDA 510(k) clearance on 2024-04-24 under 510(k) number K240319. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)?

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Pro Med Instruments GmbH. The 510(k) number is K240319.

When did DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) receive FDA 510(k) clearance?

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) received FDA 510(k) clearance on 2024-04-24, under 510(k) number K240319.

Who is the listed applicant for DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)?

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

What is the FDA product code for DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)?

The FDA product code for DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) is HBL.

列明Pro Med Instruments GmbH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。

K241883DORO无菌一次性颅骨针不锈钢，成人（36个）(3006-00)；DORO无菌一次性颅骨针不锈钢，儿童（36个）(3006-10)；DORO无菌一次性颅骨针钛，成人（36个）(3006-20)；DORO无菌一次性颅骨针钛，儿童（36个）(3006-30)；DORO无菌一次性颅骨针不锈钢，成人（36个）(3006-50)K203505DORO QR3头枕系统（铝制）K193438DORO无菌一次性颅骨针（不锈钢），DORO无菌一次性颅骨针（钛）K191740DORO LUCENT® iXI和iMRI头枕系统 K191979DORO QR3 XTom头持系统

相关器械（代码：HBL）

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。

K250423mb-FIX 颅骨稳定系统Medical Bees GmbH K241883DORO无菌一次性颅骨针不锈钢，成人（36个）(3006-00)；DORO无菌一次性颅骨针不锈钢，儿童（36个）(3006-10)；DORO无菌一次性颅骨针钛，成人（36个）(3006-20)；DORO无菌一次性颅骨针钛，儿童（36个）(3006-30)；DORO无菌一次性颅骨针不锈钢，成人（36个）(3006-50)Pro Med Instruments GmbH K203505DORO QR3头枕系统（铝制）Pro Med Instruments GmbH K193438DORO无菌一次性颅骨针（不锈钢），DORO无菌一次性颅骨针（钛）Pro Med Instruments GmbH K191740DORO LUCENT® iXI和iMRI头枕系统Pro Med Instruments GmbH K191701Arcus 头部固定框架Mri Interventions, 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。