Explorer Air II
K号: K214097 · 2022-02-25
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器械摘要
Explorer Air II is the device name listed in this FDA 510(k) record. The listed applicant is Surgvision GmbH. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K214097. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Explorer Air II?
Explorer Air II is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Surgvision GmbH. The 510(k) number is K214097.
When did Explorer Air II receive FDA 510(k) clearance?
Explorer Air II received FDA 510(k) clearance on 2022-02-25, under 510(k) number K214097.
Who is the listed applicant for Explorer Air II?
The FDA 510(k) record lists Surgvision GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Explorer Air II?
The FDA product code for Explorer Air II is IZI.
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。
列明Surgvision GmbH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：IZI）
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。
K261037780 nm SPY便携式手持成像（SPY-PHI）系统Stryker EndoscopyK253181SURGIMAGE SIM 1000H 荧光成像平台Surgimage CorporationK243645IC-Flow™成像系统2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision 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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