Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)— 510(k) K234107
Substantially EquivalentLaborie Medical Technologies, Corp.
FDA 510(k) clearance K234107 for Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212), Substantially Equivalent on 2024-04-23. Applicant: Laborie Medical Technologies, Corp.. Device class: 2.
Clearance details
- Applicant
- Laborie Medical Technologies, Corp.
- Product code
- Code KLA
- 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
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