hipEOS— 510(k) K161479

Substantially Equivalent

Onefit Medical

FDA 510(k) clearance K161479 for hipEOS, Substantially Equivalent on 2016-06-28. Applicant: Onefit Medical.

Clearance details

Applicant: Onefit Medical
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-05-31
Decision date: 2016-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Besançon, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.