FDA 510(k)

EDEN 窺視籠

K 號：K201793 · 2021-09-13

決定日期2021-09-13

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

EDEN Peek Cage is the device name listed in this FDA 510(k) record. The listed applicant is Jmt Co., Ltd.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K201793. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EDEN Peek Cage?

EDEN Peek Cage is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is Jmt Co., Ltd.. The 510(k) number is K201793.

When did EDEN Peek Cage receive FDA 510(k) clearance?

EDEN Peek Cage received FDA 510(k) clearance on 2021-09-13, under 510(k) number K201793.

Who is the listed applicant for EDEN Peek Cage?

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

What is the FDA product code for EDEN Peek Cage?

The FDA product code for EDEN Peek Cage is ODP.

其他以 Jmt Co., Ltd. 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。

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相關器械（代碼：ODP）

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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