GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION— 510(k) K131230

Substantially Equivalent

Philosys, Inc.

FDA 510(k) clearance K131230 for GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION, Substantially Equivalent on 2014-08-04. Applicant: Philosys, Inc..

Clearance details

Applicant: Philosys, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2013-04-30
Decision date: 2014-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.