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FDA 510(k)

SAPPHIRE, ELEVARE SAPPHIRE

K号: K172555 · 2018-05-01

申请人Omm Imports, Inc. D/B/A Zero Gravity
决定日期2018-05-01
产品代码OLP
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

SAPPHIRE, ELEVARE SAPPHIRE is the device name listed in this FDA 510(k) record. The listed applicant is Omm Imports, Inc. D/B/A Zero Gravity. It received FDA 510(k) clearance on 2018-05-01 under 510(k) number K172555. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SAPPHIRE, ELEVARE SAPPHIRE?

SAPPHIRE, ELEVARE SAPPHIRE is a medical device that received FDA 510(k) clearance on 2018-05-01. The listed applicant is Omm Imports, Inc. D/B/A Zero Gravity. The 510(k) number is K172555.

When did SAPPHIRE, ELEVARE SAPPHIRE receive FDA 510(k) clearance?

SAPPHIRE, ELEVARE SAPPHIRE received FDA 510(k) clearance on 2018-05-01, under 510(k) number K172555.

Who is the listed applicant for SAPPHIRE, ELEVARE SAPPHIRE?

The FDA 510(k) record lists Omm Imports, Inc. D/B/A Zero Gravity as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAPPHIRE, ELEVARE SAPPHIRE?

The FDA product code for SAPPHIRE, ELEVARE SAPPHIRE is OLP.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Omm Imports, Inc. D/B/A Zero Gravity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。

K183329激光生发治疗

相关器械（代码：OLP）

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。

K253878LUSTRE GoGlow 高级 LED 贴片（PR8001，PR9001）Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia CorporationK242068LED光疗面罩（RT01）Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED光疗面罩（E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A）Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (型号：ENEOB852)Premier North America, Inc.K230490PMD Clean痤疮清洁，型号：4004-CABLUE-NA，4004-GREY-NA，4004-YELLOW-NA，4004-PSTO-NA，4004-LPUR-NA，4004-CABLUE-NA-INT，4004-GREY-INT，4004-YELLOW-INT，4004-PSTO-INT，4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.

官方来源

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