FDA 510(k)

Cala kIQ Plus

K 號：K253587 · 2026-03-17

決定日期2026-03-17

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 kIQ Plus 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 2026-03-17 under 510(k) number K253587. 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 kIQ Plus?

Cala kIQ Plus is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Cala Health, Inc.. The 510(k) number is K253587.

When did Cala kIQ Plus receive FDA 510(k) clearance?

Cala kIQ Plus received FDA 510(k) clearance on 2026-03-17, under 510(k) number K253587.

Who is the listed applicant for Cala kIQ Plus?

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 kIQ Plus?

The FDA product code for Cala kIQ Plus 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。

K243848Cala kIQ K242259Cala kIQ K222237Cala kIQ K203288Cala 三重奏 K182706外部上肢震顫刺激器

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。

K251517Encora X1Encora, Inc.K250096Felix神經AI系統Fasikl Incorporated K243848Cala kIQCala Health, Inc.K242259Cala kIQCala Health, Inc.K222237Cala kIQCala Health, Inc.K203288Cala 三重奏Cala Health, Inc.

官方來源

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