LUCEA LED SURGICAL LIGHT SYSTEM— 510(k) K113679
Substantially EquivalentMaquet S.A.S.
FDA 510(k) clearance K113679 for LUCEA LED SURGICAL LIGHT SYSTEM, Substantially Equivalent on 2012-01-12. Applicant: Maquet S.A.S.. Device class: 2.
Clearance details
- Applicant
- Maquet S.A.S.
- Product code
- Code NTN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wayne, NJ, US
Recent devices under product code NTN
view allMore clearances from Maquet S.A.S.
view allAdverse events under product code NTN
product code NTN- Other
- 1
- Total
- 1
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 →
Recalls naming K113679
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113679.
Data sourced from openFDA. This site is unofficial and independent of the FDA.