ENT Nasopharyngoscope and Accessories— 510(k) K214050

Substantially Equivalent

Medimaging Integrated Solution, Inc (Miis)

FDA 510(k) clearance K214050 for ENT Nasopharyngoscope and Accessories, Substantially Equivalent on 2022-07-01. Applicant: Medimaging Integrated Solution, Inc (Miis).

Clearance details

Applicant: Medimaging Integrated Solution, Inc (Miis)
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2021-12-27
Decision date: 2022-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.