FDA 510(k)

IceSense 3，ProSense，MultiSense

K号: K183213 · 2019-12-20

决定日期2019-12-20

产品代码GEH

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决定实质等同

器械摘要

IceSense 3, ProSense, MultiSense is the device name listed in this FDA 510(k) record. The listed applicant is IceCure Medical , Ltd.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K183213. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IceSense 3, ProSense, MultiSense?

IceSense 3, ProSense, MultiSense is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is IceCure Medical , Ltd.. The 510(k) number is K183213.

When did IceSense 3, ProSense, MultiSense receive FDA 510(k) clearance?

IceSense 3, ProSense, MultiSense received FDA 510(k) clearance on 2019-12-20, under 510(k) number K183213.

Who is the listed applicant for IceSense 3, ProSense, MultiSense?

The FDA 510(k) record lists IceCure Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IceSense 3, ProSense, MultiSense?

The FDA product code for IceSense 3, ProSense, MultiSense is GEH.

列明IceCure Medical , 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。

K260377XSense冷冻消融系统，配备冷冻探头 K240892XSense冷冻消融系统，配备冷冻探头

相关器械（代码：GEH）

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。

K262420Maverix冷冻活检Pro（MCB Pro）（MCBP-1000）；Maverix冷冻胶囊（CC-1000）Serpex Medical K261068Maverix Cryo Biopsy Probe (MCB1000)；Maverix Cryo Cartridge (CC1000)Serpex Medical K261806ERBECRYO 2 冷冻手术单元及附件Erbe Elektromedizin GmbH K253230ERBECRYO 2 冷冻手术单元及附件：ERBECRYO 2 冷冻手术单元；Erbe 弹性冷冻探头Erbe Elektromedizin GmbH K252198高级冷冻皮肤疣去除器（高级皮肤疣去除器）Medical Brands Laboratories B.V.K260377XSense冷冻消融系统，配备冷冻探头IceCure Medical , Ltd.

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