Solar Compact (G4-1)— 510(k) K240007
Substantially EquivalentLaborie Medical Technologies, Corp.
FDA 510(k) clearance K240007 for Solar Compact (G4-1), Substantially Equivalent on 2024-05-06. Applicant: Laborie Medical Technologies, Corp.. Device class: 2.
Clearance details
- Applicant
- Laborie Medical Technologies, Corp.
- Product code
- Code FFX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portsmouth, NH, US
Recent devices under product code FFX
view allMore clearances from Laborie Medical Technologies, Corp.
view allAdverse events under product code FFX
product code FFX- Other
- 1
- Total
- 1
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.