ALPHAXENON LIGHT 180 W AND 300 W— 510(k) K093125
Substantially EquivalentGimmi GmbH
FDA 510(k) clearance K093125 for ALPHAXENON LIGHT 180 W AND 300 W, Substantially Equivalent on 2010-01-27. Applicant: Gimmi GmbH. Device class: 2.
Clearance details
- Applicant
- Gimmi GmbH
- Product code
- Code GCT
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Tuttlingen, DE
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Adverse events under product code GCT
product code GCT- Malfunction
- 1,393
- Other
- 2
- Total
- 1,395
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.