Epitomee— 510(k) K240544
Substantially EquivalentEpitomee Medical , Ltd.
FDA 510(k) clearance K240544 for Epitomee, Substantially Equivalent on 2024-09-13. Applicant: Epitomee Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Epitomee Medical , Ltd.
- Product code
- Code QFQ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5982
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Caesarea, IL
Recent devices under product code QFQ
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