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FDA 510(k)

ATMOS C 051 胸部 (317.0200.0)；800ml 分泌物罐 (317.1300.0)；软管系统 (312.1177.0)；带小连接器的软管系统 (312.1206.0)；带中等连接器的软管系统 (312.1207.0)；带大连接器的软管系统 (312.1208.0)；带Y型连接器的中等软管系统 (312.1209.0)；带Y型连接器的大软管系统 (312.1210.0)；ATMOS C 051 胸部通用托架 (316.0200.0)；ATMOS C 051 胸部 - 标准轨道托架 (317.1160.0)；ATMOS C 托架充电存储器

K号: K241799 · 2025-03-07

申请人Atmos Medizintechnik GmbH & Co. KG
决定日期2025-03-07
产品代码BTA
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决定实质等同

器械摘要

ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C is the device name listed in this FDA 510(k) record. The listed applicant is Atmos Medizintechnik GmbH & Co. KG. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K241799. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C?

ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Atmos Medizintechnik GmbH & Co. KG. The 510(k) number is K241799.

When did ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C receive FDA 510(k) clearance?

ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C received FDA 510(k) clearance on 2025-03-07, under 510(k) number K241799.

Who is the listed applicant for ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C?

The FDA 510(k) record lists Atmos Medizintechnik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C?

The FDA product code for ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C is BTA.

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Atmos Medizintechnik GmbH & Co. KG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。

K232015ATMOS 显微镜 (507.7000.0)；ATMOS 显微镜 Pro (507.7050.0)；ATMOS 显微镜 iPrime (507.7060.0)

相关器械（代码：BTA）

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。

K253629Momcozy 鼻吸器 (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby 鼻吸器（BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021）Shenzhen Root Innovation Technology Co., Ltd.K260892吸水泵（SU-90）Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473电动鼻吸器（BC027, BC030, BC033, BC035, BC035B）Shenzhen Kingboom Technology Co., Ltd.K253107电动鼻吸器 (DT10 和 DT50, DX80, DX85, DX86 和 DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147电动鼻吸器（BC026, BC025, BC023, BC028, BC029, BC036）Shenzhen Kingboom Technology Co., Ltd.

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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