NAUTILUS DELTA— 510(k) K141634

Substantially Equivalent

Romedex International Srl

FDA 510(k) clearance K141634 for NAUTILUS DELTA, Substantially Equivalent on 2015-01-27. Applicant: Romedex International Srl.

Clearance details

Applicant: Romedex International Srl
Product code: Code LJS
Advisory panel: General Hospital
Date received: 2014-06-18
Decision date: 2015-01-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.