EMV3 Self Monitoring Blood Glucose System, EMV3 Pro Self Monitoring Blood Glucose System
FDA 510(k) K111728 · Eps Bio Technology Corp.
510(k) numberK111728
Submission
- Device name
- EMV3 Self Monitoring Blood Glucose System, EMV3 Pro Self Monitoring Blood Glucose System
- Applicant
- Eps Bio Technology Corp.
Hsinchu, TW - Received
- June 20, 2011
- Decision date
- September 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K182057 | EasyMax BT Self-Monitoring Blood Glucose SystemNBW · Special | 08/24/2018SE |
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| K133647 | EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose SystemNBW · Special | 02/27/2014SE |
| K121207 | Easymax Mu Self Monitoring Blood Glucose System, Easymax Mu Pro Self Monitoring Blood…LFR · Special | 05/18/2012SE |
| K113243 | EM50 Self Monitoring Blood Glucose SystemLFR · Traditional | 03/28/2012SE |
| K112901 | Eme Self Monitoring Blood Glucose System, Eme Pro Self Monitoring Blood Glucose SystemLFR · Special | 12/23/2011SE |
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Questions and answers
When was EMV3 Self Monitoring Blood Glucose System, EMV3 Pro Self Monitoring Blood Glucose System cleared by the FDA?
EMV3 Self Monitoring Blood Glucose System, EMV3 Pro Self Monitoring Blood Glucose System (K111728) received a 510(k) decision of Substantially Equivalent on September 16, 2011, 88 days after the submission was received.
What is the product code of K111728?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.