SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100— 510(k) K052108
Substantially EquivalentSein Electronics Co., Ltd.
FDA 510(k) clearance K052108 for SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100, Substantially Equivalent on 2005-12-07. Applicant: Sein Electronics Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Sein Electronics Co., Ltd.
- Product code
- Code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Alpharetta, GA, US
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More clearances from Sein Electronics Co., Ltd.
view all- K042138 — FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311
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- K032927 — FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR
- K012054 — FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312
- K003711 — AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P
Adverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.