Glucocare Intensive Glycemic Control System
FDA 510(k) K081388 · Pronia Medical System, LLC
510(k) numberK081388
Submission
- Device name
- Glucocare Intensive Glycemic Control System
- Applicant
- Pronia Medical System, LLC
North Attleboro, MA, US - Received
- May 19, 2008
- Decision date
- August 21, 2008
- 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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| K230813 | BlueStar and BlueStar RxNDC · Traditional | Welldoc, Inc. | 07/28/2023SE |
Questions and answers
When was Glucocare Intensive Glycemic Control System cleared by the FDA?
Glucocare Intensive Glycemic Control System (K081388) received a 510(k) decision of Substantially Equivalent on August 21, 2008, 94 days after the submission was received.
What is the product code of K081388?
The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.