G+ SYSTEM— 510(k) K101344
Substantially EquivalentGlytec, LLC (Formally Known AS Glucotec, Inc.)
FDA 510(k) clearance K101344 for G+ SYSTEM, Substantially Equivalent on 2010-06-28. Applicant: Glytec, LLC (Formally Known AS Glucotec, Inc.).
Clearance details
- Applicant
- Glytec, LLC (Formally Known AS Glucotec, Inc.)
- Product code
- Code NDC
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Simpsonville, SC, US
Adverse events under product code NDC
product code NDC- Malfunction
- 1,390
- Total
- 1,390
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.