FDA 510(k)

ORS-3000LD 湿布, ORS-1000LD 液体加温布

K号: K152522 · 2016-01-15

决定日期2016-01-15

产品代码LHC

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决定实质等同

器械摘要

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes is the device name listed in this FDA 510(k) record. The listed applicant is Ecolab, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152522. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes?

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Ecolab, Inc.. The 510(k) number is K152522.

When did ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes receive FDA 510(k) clearance?

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152522.

Who is the listed applicant for ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes?

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

What is the FDA product code for ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes?

The FDA product code for ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes is LHC.

列明Ecolab, 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。

K182164Ecolab POU 水过滤器喷嘴出口，Ecolab POU 水过滤器喷嘴出口，Ecolab POU 水过滤器花洒把手 K173164Ecolab POU 水过滤器

官方来源

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