Clarian Glucose Stabilizer Insulin Dosing Calculator
FDA 510(k) K071713 · Medical Decisions Network
510(k) numberK071713
Submission
- Device name
- Clarian Glucose Stabilizer Insulin Dosing Calculator
- Applicant
- Medical Decisions Network
Washington, DC, US - Received
- June 22, 2007
- Decision date
- October 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDC – Calculator, Drug Dose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1890
- Specialty
- Anesthesiology
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| K242066 | iSage RxNDC · Traditional | Amalgam Rx, Inc. | 08/21/2024SE |
| K232451 | Insulia Bolus CompanionNDC · Traditional | Voluntis Sa. | 12/12/2023SE |
| K230813 | BlueStar and BlueStar RxNDC · Traditional | Welldoc, Inc. | 07/28/2023SE |
Questions and answers
When was Clarian Glucose Stabilizer Insulin Dosing Calculator cleared by the FDA?
Clarian Glucose Stabilizer Insulin Dosing Calculator (K071713) received a 510(k) decision of Substantially Equivalent on October 12, 2007, 112 days after the submission was received.
What is the product code of K071713?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.