FDA 510(k)

CARESCAPE R860

K 號：K210384 · 2021-11-04

決定日期2021-11-04

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

CARESCAPE R860 is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K210384. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CARESCAPE R860?

CARESCAPE R860 is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K210384.

When did CARESCAPE R860 receive FDA 510(k) clearance?

CARESCAPE R860 received FDA 510(k) clearance on 2021-11-04, under 510(k) number K210384.

Who is the listed applicant for CARESCAPE R860?

FDA 510(k) 記錄將 Datex-Ohmeda, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CARESCAPE R860?

The FDA product code for CARESCAPE R860 is CBK.

其他以 Datex-Ohmeda, 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。

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相關器械（代碼：CBK）

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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