FDA 510(k)

Circul8 Pro

K 號：K212731 · 2021-11-15

決定日期2021-11-15

產品代碼JOW

諮詢委員會履歷

決定相當於

器材摘要

Circul8 Pro is the device name listed in this FDA 510(k) record. The listed applicant is Ortho8, Inc.. It received FDA 510(k) clearance on 2021-11-15 under 510(k) number K212731. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Circul8 Pro?

Circul8 Pro is a medical device that received FDA 510(k) clearance on 2021-11-15. The listed applicant is Ortho8, Inc.. The 510(k) number is K212731.

When did Circul8 Pro receive FDA 510(k) clearance?

Circul8 Pro received FDA 510(k) clearance on 2021-11-15, under 510(k) number K212731.

Who is the listed applicant for Circul8 Pro?

The FDA 510(k) record lists Ortho8, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Circul8 Pro?

The FDA product code for Circul8 Pro is JOW.

其他以 Ortho8, Inc. 為申請人之記錄

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相關器械（代碼：JOW）

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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官方來源

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