ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS— 510(k) K131946

Substantially Equivalent

Pentax Medical Company

FDA 510(k) clearance K131946 for ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS, Substantially Equivalent on 2014-04-25. Applicant: Pentax Medical Company.

Clearance details

Applicant: Pentax Medical Company
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2013-06-27
Decision date: 2014-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montvale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.