iSR’obot 莫娜丽莎 2.0
K号: K213411 · 2021-12-22
广告
器械摘要
iSR’obot Mona Lisa 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213411. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iSR’obot Mona Lisa 2.0?
iSR’obot Mona Lisa 2.0 is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Biobot Surgical Pte., Ltd.. The 510(k) number is K213411.
When did iSR’obot Mona Lisa 2.0 receive FDA 510(k) clearance?
iSR’obot Mona Lisa 2.0 received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213411.
Who is the listed applicant for iSR’obot Mona Lisa 2.0?
The FDA 510(k) record lists Biobot Surgical Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iSR’obot Mona Lisa 2.0?
The FDA product code for iSR’obot Mona Lisa 2.0 is IYO.
列明Biobot Surgical Pte., Ltd.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：IYO）
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。
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