FDA 510(k)

ORS-3000LD 雪花式覆蓋布，ORS-1000LD 液體加熱覆蓋布

K 號：K152522 · 2016-01-15

決定日期2016-01-15

產品代碼LHC

諮詢委員會PM

決定相當於

器材摘要

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.

常見問題

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.

其他以 Ecolab, Inc. 為申請人之記錄

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相關器械（代碼：LHC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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