FDA 510(k)

SAM CRRT 单元，SAM 卡匣 CRRT

K号: K170790 · 2017-12-13

决定日期2017-12-13

产品代码KDI

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决定实质等同

器械摘要

SAM CRRT Unit, SAM Cassette CRRT is the device name listed in this FDA 510(k) record. The listed applicant is Spectral Medical, Inc.. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K170790. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SAM CRRT Unit, SAM Cassette CRRT?

SAM CRRT Unit, SAM Cassette CRRT is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Spectral Medical, Inc.. The 510(k) number is K170790.

When did SAM CRRT Unit, SAM Cassette CRRT receive FDA 510(k) clearance?

SAM CRRT Unit, SAM Cassette CRRT received FDA 510(k) clearance on 2017-12-13, under 510(k) number K170790.

Who is the listed applicant for SAM CRRT Unit, SAM Cassette CRRT?

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

What is the FDA product code for SAM CRRT Unit, SAM Cassette CRRT?

The FDA product code for SAM CRRT Unit, SAM Cassette CRRT is KDI.

列明Spectral Medical, Inc.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。

K183176内毒素活性测定（EAA）

相关器械（代码：KDI）

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。

K261267Careflux H60；Careflux H70；Careflux V500Fresenius Medical Care Renal Therapies Group, LLC K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC K260533ELISIO™-HNipro Medical Corporation K252459multiFlux 130（F00013123）；multiFlux 160（F00013124）Fresenius Medical Care Renal Therapies Group, LLC K253412Tablo血液透析系统（PN-0008000，PN-0006000U）Outset Medical, Inc.K253518FX CorAL 40；FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

官方来源

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