FDA 510(k)

PEAK NS033CF, PEAK NS017CF

K 號：K180565 · 2018-06-13

決定日期2018-06-13

產品代碼ELW

諮詢委員會DE

決定相當於

器材摘要

PEAK NS033CF, PEAK NS017CF is the device name listed in this FDA 510(k) record. The listed applicant is Neosil Co., Ltd.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K180565. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PEAK NS033CF, PEAK NS017CF?

PEAK NS033CF, PEAK NS017CF is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Neosil Co., Ltd.. The 510(k) number is K180565.

When did PEAK NS033CF, PEAK NS017CF receive FDA 510(k) clearance?

PEAK NS033CF, PEAK NS017CF received FDA 510(k) clearance on 2018-06-13, under 510(k) number K180565.

Who is the listed applicant for PEAK NS033CF, PEAK NS017CF?

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

What is the FDA product code for PEAK NS033CF, PEAK NS017CF?

The FDA product code for PEAK NS033CF, PEAK NS017CF is ELW.

相關器械（代碼：ELW）

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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