EXPLORER AIR® II
K号: K222240 · 2023-02-28
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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 2023-02-28 under 510(k) number K222240. 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 2023-02-28. The listed applicant is Surgvision GmbH. The 510(k) number is K222240.
When did EXPLORER AIR® II receive FDA 510(k) clearance?
EXPLORER AIR® II received FDA 510(k) clearance on 2023-02-28, under 510(k) number K222240.
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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