CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K111268
Substantially EquivalentBayer Healthcare
FDA 510(k) clearance K111268 for CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-03-06. Applicant: Bayer Healthcare. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare
- 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
- Traditional
- Location
- Mishawaka, IN, US
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More clearances from Bayer Healthcare
view allAdverse 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 →
Recalls naming K111268
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111268.
Data sourced from openFDA. This site is unofficial and independent of the FDA.