CONTOUR NEXT BLOOD GLUCOSE METER— 510(k) K121190
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K121190 for CONTOUR NEXT BLOOD GLUCOSE METER, Substantially Equivalent on 2012-07-26. Applicant: Bayer Healthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code LFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tarrytown, NY, US
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More clearances from Bayer Healthcare, LLC
view all- K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
- K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
- K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER
- K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
- K093930 — DIDGET WORLD REPORTS
Adverse events under product code LFR
product code LFR- Death
- 3
- Malfunction
- 1,634
- Total
- 1,637
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.