FDA 510(k)

cNeuro cPET

K 號：K231576 · 2023-09-14

決定日期2023-09-14

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

cNeuro cPET is the device name listed in this FDA 510(k) record. The listed applicant is Combinostics OY. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K231576. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the cNeuro cPET?

cNeuro cPET is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Combinostics OY. The 510(k) number is K231576.

When did cNeuro cPET receive FDA 510(k) clearance?

cNeuro cPET received FDA 510(k) clearance on 2023-09-14, under 510(k) number K231576.

Who is the listed applicant for cNeuro cPET?

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

What is the FDA product code for cNeuro cPET?

The FDA product code for cNeuro cPET is KPS.

其他以 Combinostics OY 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。

K233908cNeuro cDAT K171328cNeuro cMRI

相關器械（代碼：KPS）

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。

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。