ENTity WiFi Video Nasopharyngoscope System— 510(k) K200609

Substantially Equivalent

Optim, LLC

FDA 510(k) clearance K200609 for ENTity WiFi Video Nasopharyngoscope System, Substantially Equivalent on 2021-01-13. Applicant: Optim, LLC.

Clearance details

Applicant: Optim, LLC
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2020-03-09
Decision date: 2021-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturbridge, MA, US

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.