K222587

Substantially Equivalent

PatCom Distal Chip Endoscope

Applicant: H&A Mui Enterprises, Inc.
Product code: EOB
Advisory panel: Ear, Nose, Throat
Date received: 2022-08-26
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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.