hipEOS— 510(k) K161479
Substantially EquivalentOnefit Medical
FDA 510(k) clearance K161479 for hipEOS, Substantially Equivalent on 2016-06-28. Applicant: Onefit Medical. Device class: 2.
Clearance details
- Applicant
- Onefit Medical
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Besançon, FR
Recent devices under product code LLZ
view allMore clearances from Onefit Medical
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.