MiVu Esophageal Endo Cap— 510(k) K230056

Substantially Equivalent

Diversatek Healthcare

FDA 510(k) clearance K230056 for MiVu Esophageal Endo Cap, Substantially Equivalent on 2023-04-25. Applicant: Diversatek Healthcare. Device class: 2.

Clearance details

Applicant: Diversatek Healthcare
Product code: Code QIS
Device class: Class 2
Regulation: 21 CFR 876.1450
Advisory panel: Gastroenterology, Urology
Date received: 2023-01-09
Decision date: 2023-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highlands Ranch, CO, US

Download summary PDF View on FDA.gov ↗

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