TYSONBIO LINK HEALTH MANAGEMENT SYSTEM— 510(k) K081726
Substantially EquivalentTyson Bioresearch, Inc.
FDA 510(k) clearance K081726 for TYSONBIO LINK HEALTH MANAGEMENT SYSTEM, Substantially Equivalent on 2008-08-26. Applicant: Tyson Bioresearch, Inc.. Device class: 2.
Clearance details
- Applicant
- Tyson Bioresearch, Inc.
- 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
- Traditional
- Location
- Chun-Nan, Miao-Li County, TW
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More clearances from Tyson Bioresearch, Inc.
view all- K182046 — Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
- K182047 — Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
- K170079 — Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System
- K123087 — TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
- K112916 — TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM
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.