C-QUEST— 510(k) K992103

Substantially Equivalent

Wuestec Medical, Inc.

FDA 510(k) clearance K992103 for C-QUEST, Substantially Equivalent on 1999-09-01. Applicant: Wuestec Medical, Inc..

Clearance details

Applicant: Wuestec Medical, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 1999-06-22
Decision date: 1999-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mobile, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.