FDA 510(k)

彩虹LS壓縮器

K 號：K151846 · 2016-01-14

申請人Genoss

決定日期2016-01-14

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

Rainbow LS Pressing is the device name listed in this FDA 510(k) record. The listed applicant is Genoss. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K151846. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Rainbow LS Pressing?

Rainbow LS Pressing is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Genoss. The 510(k) number is K151846.

When did Rainbow LS Pressing receive FDA 510(k) clearance?

Rainbow LS Pressing received FDA 510(k) clearance on 2016-01-14, under 510(k) number K151846.

Who is the listed applicant for Rainbow LS Pressing?

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

What is the FDA product code for Rainbow LS Pressing?

The FDA product code for Rainbow LS Pressing is EIH.

其他以 Genoss 為申請人之記錄

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。

K151731彩虹膠膠標記 K151842彩虹閃耀

相關器械（代碼：EIH）

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。

K262074任何-錫科斯Mediclus Co., Ltd.K262239Obsidian® 压克力壓克力超過鎂鋁Prismatik Dentalcraft, Inc.K261046牙醫用氧化鋁陶瓷空白片及上色液Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy陶瓷染色及釉料Zima International Inc., dba Dandy K260918佐立隆尼士Amann Girrbach AG K260859羅塞塔SM，羅塞塔SPHass Corp.

官方來源

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