Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100
FDA 510(k) K052108 · Sein Electronics Co., Ltd.
510(k) numberK052108
Submission
- Device name
- Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100
- Applicant
- Sein Electronics Co., Ltd.
Alpharetta, GA, US - Received
- August 3, 2005
- Decision date
- December 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K042138 | Full Auto Wrist Digital Blood Pressure Monitor Model# SE-311DXN · Special | 08/24/2004SE |
| K042014 | Digital Blood Pressure Monitor, Models SE-9000, SE-9200 and SE-9400DXN · Special | 08/06/2004SE |
| K032927 | Full Auto Arm Digital Blood Pressure MonitorDXN · Traditional | 05/07/2004SE |
| K012054 | Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312DXN · Traditional | 08/08/2001SE |
| K003711 | Ambulatory Blood Pressure Monitoring System, Model SE-25M/25PDXN · Traditional | 12/15/2000SE |
| K003282 | Full Auto Blood Pressure Monitor, Model SE-7700HDXN · Traditional | 11/01/2000SE |
| K991397 | Transcutaneous Electrical Nerve Stimulator SE-30 TENSGZJ · Traditional | 02/11/2000SE |
| K973078 | Wrist Blood Pressure Meter Model SE-330DPW · Traditional | 05/20/1999SE |
| K952827 | Full Auto Wrist Blood Pressure Meter Model SE-5000DXN · Traditional | 11/14/1996SE |
| K952826 | Full Auto Fuzzy Blood Pressure Meter Model SE-7000DXN · Traditional | 11/14/1996SE |
Questions and answers
When was Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 cleared by the FDA?
Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 (K052108) received a 510(k) decision of Substantially Equivalent on December 7, 2005, 126 days after the submission was received.
What is the product code of K052108?
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.