Keffort (MC-100, MC-100A)— 510(k) K213133
Substantially EquivalentOriental Inspiration Limited
FDA 510(k) clearance K213133 for Keffort (MC-100, MC-100A), Substantially Equivalent on 2022-04-13. Applicant: Oriental Inspiration Limited. Device class: 2.
Clearance details
- Applicant
- Oriental Inspiration Limited
- 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
- Hong Kong, CN
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More clearances from Oriental Inspiration Limited
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