Solar Compact (G4-1)
FDA 510(k) clearance K240007 · decided 2024-05-06
Clearance details
- K-number
- K240007
- Device name
- Solar Compact (G4-1)
- Applicant
- Laborie Medical Technologies, Corp.
- Decision
- Substantially Equivalent
- Date received
- 2024-01-02
- Decision date
- 2024-05-06
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Portsmouth, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.