Dr J 脊髓和硬脊膜外针
K号: K183316 · 2019-08-12
广告
决定日期2019-08-12
产品代码BSP
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
Dr J Spinal and Epidural Needles is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Japan Co., Ltd.. It received FDA 510(k) clearance on 2019-08-12 under 510(k) number K183316. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dr J Spinal and Epidural Needles?
Dr J Spinal and Epidural Needles is a medical device that received FDA 510(k) clearance on 2019-08-12. The listed applicant is Dr. Japan Co., Ltd.. The 510(k) number is K183316.
When did Dr J Spinal and Epidural Needles receive FDA 510(k) clearance?
Dr J Spinal and Epidural Needles received FDA 510(k) clearance on 2019-08-12, under 510(k) number K183316.
Who is the listed applicant for Dr J Spinal and Epidural Needles?
The FDA 510(k) record lists Dr. Japan Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dr J Spinal and Epidural Needles?
The FDA product code for Dr J Spinal and Epidural Needles is BSP.
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。
相关器械（代码：BSP）
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。
K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM；SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® 标准型 (LUER/ NRFit®) 腰椎穿刺PAJUNK GmbH MedizintechnologieK243525SonoTAP和SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® 标准型 (LUER/ NRFit®) 麻醉学PAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie
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。
广告