ELIMINATOR AIR FILTER— 510(k) K882468

Substantially Equivalent

Apex Medical, Inc.

FDA 510(k) clearance K882468 for ELIMINATOR AIR FILTER, Substantially Equivalent on 1988-08-29. Applicant: Apex Medical, Inc..

Clearance details

Applicant: Apex Medical, Inc.
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 1988-06-15
Decision date: 1988-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinsville, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.