GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K132966
Substantially EquivalentInfopia Co, Ltd.
FDA 510(k) clearance K132966 for GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2013-12-05. Applicant: Infopia Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Infopia Co, Ltd.
- Product code
- Product 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
- Anaheim, CA, US
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More clearances from Infopia Co, Ltd.
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- K141750 — HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
- K132406 — ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM
- K133045 — ELEMENT TM LITE BLOOD GLUCOSE 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.