AVIA PAIN MEDICATION DELIVERY SYSTEM— 510(k) K990312

Substantially Equivalent

Amtec Medical

FDA 510(k) clearance K990312 for AVIA PAIN MEDICATION DELIVERY SYSTEM, Substantially Equivalent on 1999-04-22. Applicant: Amtec Medical.

Clearance details

Applicant: Amtec Medical
Product code: Code MEA
Advisory panel: General Hospital
Date received: 1999-02-01
Decision date: 1999-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEA

product code MEA

Death: 19
Malfunction: 25,089
Total: 25,108

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.