FDA 510(k)

OtoSight 中耳鏡

K 號：K222655 · 2022-09-26

決定日期2022-09-26

產品代碼QJG

諮詢委員會RA

決定相當於

器材摘要

OtoSight Middle Ear Scope is the device name listed in this FDA 510(k) record. The listed applicant is Photonicare, Inc.. It received FDA 510(k) clearance on 2022-09-26 under 510(k) number K222655. The device is classified under product code QJG. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OtoSight Middle Ear Scope?

OtoSight Middle Ear Scope is a medical device that received FDA 510(k) clearance on 2022-09-26. The listed applicant is Photonicare, Inc.. The 510(k) number is K222655.

When did OtoSight Middle Ear Scope receive FDA 510(k) clearance?

OtoSight Middle Ear Scope received FDA 510(k) clearance on 2022-09-26, under 510(k) number K222655.

Who is the listed applicant for OtoSight Middle Ear Scope?

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

What is the FDA product code for OtoSight Middle Ear Scope?

The FDA product code for OtoSight Middle Ear Scope is QJG.

其他以 Photonicare, Inc. 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。

K191804TOMi 視野

相關器械（代碼：QJG）

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。

K191804TOMi 視野Photonicare, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。