GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATION— 510(k) K131230
Substantially EquivalentPhilosys, 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.. Device class: 2.
Clearance details
- Applicant
- Philosys, Inc.
- 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
- New York, NY, US
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More clearances from Philosys, Inc.
view allAdverse 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.