ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105— 510(k) K080622

Substantially Equivalent

Optim, Inc.

FDA 510(k) clearance K080622 for ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105, Substantially Equivalent on 2008-04-02. Applicant: Optim, Inc..

Clearance details

Applicant: Optim, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2008-03-05
Decision date: 2008-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Sturbridge, MA, US

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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.