NATUS WARMETTE BLANKET AND DUAL CABINETS— 510(k) K132110

Substantially Equivalent

Natus 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..

Clearance details

Applicant: Natus Nicolet Ireland, Ltd.
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2013-07-09
Decision date: 2013-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gort, County Galway, IE

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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.