APEX— 510(k) K141158
Substantially EquivalentIncontrol Medical, LLC
FDA 510(k) clearance K141158 for APEX, Substantially Equivalent on 2014-11-26. Applicant: Incontrol Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Incontrol Medical, LLC
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brookfield, WI, US
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More clearances from Incontrol Medical, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.