NATUS WARMETTE BLANKET AND DUAL CABINETS— 510(k) K132110
Substantially EquivalentNatus Nicolet Ireland, Ltd.
FDA 510(k) clearance K132110 for NATUS WARMETTE BLANKET AND DUAL CABINETS, Substantially Equivalent on 2013-10-03. Applicant: Natus Nicolet Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Natus Nicolet Ireland, Ltd.
- Product code
- Code LGZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gort, County Galway, IE
Recent devices under product code LGZ
view allAdverse events under product code LGZ
product code LGZ- Death
- 16
- Malfunction
- 5,916
- Other
- 1
- Total
- 5,933
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 K132110
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 K132110.
Data sourced from openFDA. This site is unofficial and independent of the FDA.