ENT Nasopharyngoscope and Accessories— 510(k) K214050
Substantially EquivalentMedimaging 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). Device class: 2.
Clearance details
- Applicant
- Medimaging Integrated Solution, Inc (Miis)
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsinchu, TW
Recent devices under product code EOB
view all- K261544 — Hydro Irrigation System
- K254133 — ENTity USB Videoscope System
- K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
- K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
- K241731 — Outlook Surgical Versa One System (8900139)
More clearances from Medimaging Integrated Solution, Inc (Miis)
view all- K253217 — MiiS Horus Arthroscope (EJA 100) +2 more
- K234113 — MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
- K223926 — VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
- K193188 — MiiS Horus Eye Anterior Camera
- K181260 — MiiS Horus Scope DPT 100
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . 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.