Green X 21 (PHT-90CHO)
K号: K243081 · 2025-02-14
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器械摘要
Green X 21 (PHT-90CHO) is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2025-02-14 under 510(k) number K243081. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Green X 21 (PHT-90CHO)?
Green X 21 (PHT-90CHO) is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K243081.
When did Green X 21 (PHT-90CHO) receive FDA 510(k) clearance?
Green X 21 (PHT-90CHO) received FDA 510(k) clearance on 2025-02-14, under 510(k) number K243081.
Who is the listed applicant for Green X 21 (PHT-90CHO)?
The FDA 510(k) record lists VATECH Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Green X 21 (PHT-90CHO)?
The FDA product code for Green X 21 (PHT-90CHO) is OAS.
相关临床试验
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列明VATECH Co., 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。
K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)K243088Green X 12 SE (PHT-40CHS)K240040VistaPano S Ceph 2.0（VistaPano S Ceph）；VistaPano S 2.0（VistaPano S）；ProVecta S-Pan Ceph 2.0（ProVecta S-Pan Ceph）；ProVecta S-Pan 2.0（ProVecta S-Pan）K231796Grreen X 12（型号：PHT-75CHS）K223058EzRay Air 2 Wall (型号：VEX-S350W)K213462EzRay M18 (型号：VMX-P400)
相关器械（代码：OAS）
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。
K261748牙科锥形束计算机断层扫描（mDX-15P系列）Hefei Meyer Optoelectronic Technology, Inc.K250839牙科 X-ray 系统Changzhou Boen Zhongding Medical Technology Co., Ltd.K260662牙科锥形束CT系统Yofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.
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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