Diabetesmanager System, Diabetesmanager-Rx System Model Version 1.1
FDA 510(k) K100066 · Welldoc, Inc.
510(k) numberK100066
Submission
- Device name
- Diabetesmanager System, Diabetesmanager-Rx System Model Version 1.1
- Applicant
- Welldoc, Inc.
Baltimore, MD, US - Received
- January 11, 2010
- Decision date
- July 15, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRZ – Accessories, Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K201634 | RG 3ml Medication CartridgeMRZ · Traditional | Chengdu Shifeng Medical Technology Co., Ltd. | 03/26/2021SE |
| K193654 | BlueStar RxMRZ · Traditional | Welldoc, Inc. | 04/07/2020SE |
| K191910 | SpaceStation MRIMRZ · Traditional | B. Braun Melsugen AG | 03/12/2020SE |
| K190013 | WellDoc BlueStarMRZ · Traditional | Welldoc, Inc. | 11/04/2019SE |
| K173531 | Lockbox for Perfusor Space PCA Infusion PumpMRZ · Traditional | B.Braun Medical, Inc. | 08/02/2018SE |
| K171346 | Sapphire SetsMRZ · Traditional | Icu Medical | 08/25/2017SE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar RxMRZ · Traditional | Welldoc, Inc. | 01/12/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | Hospira, Inc. | 12/06/2016SE |
More from Hospira, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K222888 | BlueStar CGM insulin dose calculatorQRX · Traditional | 08/11/2023SE |
| K230813 | BlueStar and BlueStar RxNDC · Traditional | 07/28/2023SE |
| K203434 | BlueStar RxNDC · Traditional | 09/08/2021SE |
| K193654 | BlueStar RxMRZ · Traditional | 04/07/2020SE |
| K190013 | WellDoc BlueStarMRZ · Traditional | 11/04/2019SE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar RxMRZ · Traditional | 01/12/2017SE |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemMRZ · Traditional | 11/22/2016SE |
| K141273 | Welldoc Diabetesmanager System and Diabetesmanager- RX SysteMRZ · Special | 07/08/2014SE |
| K120314 | Welldoc Diabetes Manager System and Diabetes Manager RX SystemMRZ · Special | 02/24/2012SE |
| K112370 | Welldoc Diabetes Manager System and Diabetes Manager RX SystemMRZ · Special | 10/14/2011SE |
Questions and answers
When was Diabetesmanager System, Diabetesmanager-Rx System Model Version 1.1 cleared by the FDA?
Diabetesmanager System, Diabetesmanager-Rx System Model Version 1.1 (K100066) received a 510(k) decision of Substantially Equivalent on July 15, 2010, 185 days after the submission was received.
What is the product code of K100066?
The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.