FDA 510(k)

Omnipod 5 智能輸注計算器

K 號：K203772 · 2022-01-27

決定日期2022-01-27

產品代碼QRX

諮詢委員會CH

決定相當於

器材摘要

Omnipod 5 SmartBolus Calculator is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K203772. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Omnipod 5 SmartBolus Calculator?

Omnipod 5 SmartBolus Calculator is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Insulet Corporation. The 510(k) number is K203772.

When did Omnipod 5 SmartBolus Calculator receive FDA 510(k) clearance?

Omnipod 5 SmartBolus Calculator received FDA 510(k) clearance on 2022-01-27, under 510(k) number K203772.

Who is the listed applicant for Omnipod 5 SmartBolus Calculator?

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 5 SmartBolus Calculator?

The FDA product code for Omnipod 5 SmartBolus Calculator is QRX.

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。

K261461Omnipod 6 適配演算法 K251779Omnipod 5 適配演算法 K241777SmartAdjust™ 技術 K232741SmartAdjust(TM) 技術 K231826Omnipod 5 ACE 泵 K231824智慧輸注計算器

查看所有 19 項裝置 →

相關器械（代碼：QRX）

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。

K260062MODI系統DreaMed Diabetes, Ltd.K252818Dexcom 智能基礎Dexcom, Inc.K231824智慧輸注計算器Insulet Corporation K222888藍星CGM胰島素劑量計算器Welldoc, Inc.K222239智慧輸注計算器Insulet Corporation

官方來源

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