Evencare Blood Glucose Monitoring System
FDA 510(k) K011240 · Medline Industries, Inc.
510(k) numberK011240
Submission
- Device name
- Evencare Blood Glucose Monitoring System
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- April 23, 2001
- Decision date
- September 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
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Questions and answers
When was Evencare Blood Glucose Monitoring System cleared by the FDA?
Evencare Blood Glucose Monitoring System (K011240) received a 510(k) decision of Substantially Equivalent on September 13, 2001, 143 days after the submission was received.
What is the product code of K011240?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.