FDA 510(k)

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

K号: K232015 · 2023-08-03

决定日期2023-08-03

产品代码EOB

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) 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 2023-08-03 under 510(k) number K232015. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)?

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Atmos Medizintechnik GmbH & Co. KG. The 510(k) number is K232015.

When did ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) receive FDA 510(k) clearance?

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) received FDA 510(k) clearance on 2023-08-03, under 510(k) number K232015.

Who is the listed applicant for ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)?

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 Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)?

The FDA product code for ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) is EOB.

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。

K241799ATMOS 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

官方来源

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