FDA 510(k)

Cala 三重奏

K 號：K203288 · 2021-10-05

決定日期2021-10-05

產品代碼QBC

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Cala Trio is the device name listed in this FDA 510(k) record. The listed applicant is Cala Health, Inc.. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K203288. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cala Trio?

Cala Trio is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Cala Health, Inc.. The 510(k) number is K203288.

When did Cala Trio receive FDA 510(k) clearance?

Cala Trio received FDA 510(k) clearance on 2021-10-05, under 510(k) number K203288.

Who is the listed applicant for Cala Trio?

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

What is the FDA product code for Cala Trio?

The FDA product code for Cala Trio is QBC.

其他以 Cala Health, 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：QBC）

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。

K253587Cala kIQ PlusCala Health, Inc.K251517Encora X1Encora, Inc.K250096Felix神經AI系統Fasikl Incorporated K243848Cala kIQCala Health, Inc.K242259Cala kIQCala Health, Inc.K222237Cala kIQCala Health, Inc.

官方來源

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