EASY2CHECK Blood Glucose and Blood Pressure Monitoring System
FDA 510(k) K082521 · Card Guard Scientific Survival , Ltd.
510(k) numberK082521
Submission
- Device name
- EASY2CHECK Blood Glucose and Blood Pressure Monitoring System
- Applicant
- Card Guard Scientific Survival , Ltd.
Rehovot, IL - Received
- September 2, 2008
- Decision date
- January 16, 2009
- 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
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 |
|---|---|---|
| K111745 | King of Hearts Express Af Cardiac Event RecorderDSH · Special | 08/01/2011SE |
| K110499 | CG-5108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorDSI · Special | 04/06/2011SE |
| K101703 | Modification to: CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, Model…DSI · Special | 07/13/2010SE |
| K101639 | CG-6108 Act-Il Continuous ECG Monitor and Arrythmia DetectorDSI · Special | 06/25/2010SE |
| K083174 | HealthepodDXH · Traditional | 12/17/2009SE |
| K081257 | CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia DetectorDSI · Special | 05/29/2008SE |
| K071995 | CG-6108 Continuous ECG Monitor and Arrhythmia DetectorDSI · Traditional | 12/18/2007SE |
| K061428 | PMP4 ApplicationMSX · Traditional | 10/16/2006SE |
| K061528 | Selfcheck GlucoCGA · Traditional | 09/22/2006SE |
| K060911 | CG-6108 Arrhythmia ECG Event RecorderDXH · Special | 08/22/2006SE |
Questions and answers
When was EASY2CHECK Blood Glucose and Blood Pressure Monitoring System cleared by the FDA?
EASY2CHECK Blood Glucose and Blood Pressure Monitoring System (K082521) received a 510(k) decision of Substantially Equivalent on January 16, 2009, 136 days after the submission was received.
What is the product code of K082521?
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.