XR-MX/1000
K号: K200965 · 2020-12-29
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器械摘要
XR-MX/1000 is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2020-12-29 under 510(k) number K200965. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XR-MX/1000?
XR-MX/1000 is a medical device that received FDA 510(k) clearance on 2020-12-29. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K200965.
When did XR-MX/1000 receive FDA 510(k) clearance?
XR-MX/1000 received FDA 510(k) clearance on 2020-12-29, under 510(k) number K200965.
Who is the listed applicant for XR-MX/1000?
The FDA 510(k) record lists Karl Storz Endoscopy America, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XR-MX/1000?
The FDA product code for XR-MX/1000 is JAA.
列明Karl Storz Endoscopy America, Inc.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。
K252624KARL STORZ 喉镜和附件K240506KARL STORZ 托架K223885HOPKINS 望远镜K230359KOH 超微注射针 (26167NN)；吸引和冲洗针，L. 36cm (37360CP)；吸引和冲洗针，L. 36cm (37360SC)；吸引和冲洗针，L. 36cm (37560LH)；吸引和冲洗针，L. 30cm (37260LH)；KOH 超微注射针 (26167NA)；穿刺针，LUER-lock (26178R)；吸引和冲洗针，L. 43cm (37460LH)；吸引和冲洗针，L. 36cm (37360LH)；穿刺针，直径 1.6 mm，36 cm (26175R)；双向旋塞 (26167H)；注射针，LUER-K223520UNIDRIVE SIII 系统K223923HOPKINS 望远镜
相关器械（代码：JAA）
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。
K253103Nexus DRF 数字X射线成像系统Varex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT 移动荧光透视系统Dornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH
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。
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