Hexagen Derm— 510(k) K171191
Substantially EquivalentGlobal Health Solutions, LLC
FDA 510(k) clearance K171191 for Hexagen Derm, Substantially Equivalent on 2017-08-25. Applicant: Global Health Solutions, LLC.
Clearance details
- Applicant
- Global Health Solutions, LLC
- Product code
- Code FRO
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rome, GA, US
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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.