OW100S
K号: K231710 · 2023-09-01
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器械摘要
OW100S is the device name listed in this FDA 510(k) record. The listed applicant is Softwave/Trt, LLC. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K231710. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OW100S?
OW100S is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Softwave/Trt, LLC. The 510(k) number is K231710.
When did OW100S receive FDA 510(k) clearance?
OW100S received FDA 510(k) clearance on 2023-09-01, under 510(k) number K231710.
Who is the listed applicant for OW100S?
The FDA 510(k) record lists Softwave/Trt, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OW100S?
The FDA product code for OW100S is PZL.
列明Softwave/Trt, LLC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。
相关器械（代码：PZL）
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。
K243279DOLORCLAST聚焦冲击波E.M.S Electro Medical Systems S.AK250779CS-Pro MEDCurative Sound TherapeuticsK233937OW100SSoftwave/Trt, LLCK202112Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia HandpieceStorz Medical AGK200926OrthoGold 100Tissue Regeneration Technologies, LLCK191961OrthoGoldTissue Regeneration Technologies
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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