EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose System
FDA 510(k) K133647 · Eps Bio Technology Corp.
510(k) numberK133647
Submission
- Device name
- EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose System
- Applicant
- Eps Bio Technology Corp.
Hsinchu, TW - Received
- November 27, 2013
- Decision date
- February 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code NBW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| 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 |
More from Ascensia Diabetes Care
| 510(k) | Device | Decision |
|---|---|---|
| K201258 | EASYMAX Tag Self-Monitoring Blood Glucose SystemNBW · Special | 09/01/2021SE |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose SystemNBW · Special | 11/01/2019SE |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose SystemNBW · Special | 08/24/2018SE |
| K133537 | EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemLFR · Special | 04/28/2014SE |
| K133389 | EM40 Self-Monitoring Blood Glucose SystemNBW · Special | 04/15/2014SE |
| 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 |
| K111728 | EMV3 Self Monitoring Blood Glucose System, EMV3 Pro Self Monitoring Blood Glucose SystemCGA · Special | 09/16/2011SE |
| K112272 | EM44 Self Monitoring Blood Glucose System, EM44 Pro Self Monitoring Blood Glucose SystemLFR · Special | 09/07/2011SE |
Questions and answers
When was EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose System cleared by the FDA?
EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose System (K133647) received a 510(k) decision of Substantially Equivalent on February 27, 2014, 92 days after the submission was received.
What is the product code of K133647?
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.