MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS— 510(k) K081703
Substantially EquivalentEntra Health Systems, Ltd.
FDA 510(k) clearance K081703 for MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS, Substantially Equivalent on 2009-01-08. Applicant: Entra Health Systems, Ltd.. Device class: 2.
Clearance details
- Applicant
- Entra Health Systems, 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
- Traditional
- Location
- Pleasanton, CA, US
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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.