FDA 510(k)

Omnipod 6 適配演算法

K 號：K261461 · 2026-06-29

決定日期2026-06-29

產品代碼QJI

諮詢委員會CH

決定相當於

器材摘要

Omnipod 6 algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K261461. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Omnipod 6 algorithm?

Omnipod 6 algorithm is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Insulet Corporation. The 510(k) number is K261461.

When did Omnipod 6 algorithm receive FDA 510(k) clearance?

Omnipod 6 algorithm received FDA 510(k) clearance on 2026-06-29, under 510(k) number K261461.

Who is the listed applicant for Omnipod 6 algorithm?

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

What is the FDA product code for Omnipod 6 algorithm?

The FDA product code for Omnipod 6 algorithm is QJI.

其他以 Insulet Corporation 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：QJI）

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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