ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION— 510(k) K120558

Substantially Equivalent

Lifescan, Inc.

FDA 510(k) clearance K120558 for ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION, Substantially Equivalent on 2013-02-07. Applicant: Lifescan, Inc..

Clearance details

Applicant: Lifescan, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2012-02-24
Decision date: 2013-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, 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, 2020-01-01 through 2026-04-23. 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.